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FullTime
Allen, TX
Posted 1 day ago
As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: Help Desk Technician   Reports to: Corporate IT Director   Department: Information Technology   Location: Allen, TX 75002   Summary: This position will assist staff with technical support of desktop computers, applications and related technology. Support includes specifications, installation and testing of computer systems and peripherals within established guidelines. Employee will also assist in the maintenance and testing of network servers, and associated equipment.   Requirements:
  • Minimum of 2+ years in a manufacturing environment
  • Networking equipment, wireless networking, VPN & firewall
  • ERP and data collections software / hardware
  • Phone systems
  • Endpoint protection products, patching & updating systems
  Responsibilities:
  • Experience with Microsoft Windows 10, Server 2012R2, 2016, 2019; Microsoft Office and PDF  Software
  • Computer hardware/software installation, diagnosis, troubleshooting and repair
  • Peripheral installation, diagnosis, troubleshooting and repair (printers, scanners, etc.)
  • Mobile device configuration (Apple IOS, Android)
  • Knowledge of basic networking fundamentals
  • Knowledge of Active Directory, DFS, DNS
  • Excellent communications and organization skills
  • Ability to work effectively as a team member demonstrating collaborative interaction with peers
  • Must maintain confidentiality and discretion
  Notables / Benefits:
  • Mid-size company with great company culture that is well diverse
  • Have a voice in the company
  • Average tenure for employee population is 7+ years
  • 401k with employee matching available
  • Paid vacation, health/dental/vision, and other excellent benefits
    An Equal Opportunity Employer

Job Features

Job Category

Information Technology

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensur...

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FullTime
Allen, TX
Posted 2 days ago
As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: R&D Engineer II   Reports to: Director, R&D Engineering   Location: Allen, TX 75002   Summary: The R&D Engineer II will design and develop new products within the existing product portfolio (Cardiac Surgery, Ophthalmology, and IV Therapy) as well as new markets for Quest Medical.  The R&D Engineer II/III will be the project leader for these products and will be expected to lead a cross-functional team to ensure all phases of the design controls process are delivered within project timelines and budgets.  The R&D Engineer II/III will also be responsible for the technical design and engineering of the products ensuring that all requirements are met.  Additionally, this individual will also be expected to participate in ongoing sustaining engineering projects and CAPA projects to provide technical support, as required.   Requirements:
  • Bachelor of Science degree in a technical field such as biomedical engineering, polymer science, chemistry, chemical engineering, mechanical engineering, or other engineering field is required.
  • Minimum of 4 years of experience in design and development of products with project management experience. Applicants with an advanced degree in the above technical fields may be considered with lesser experience.
  • Project management experience and knowledge of design control processes and QSR.
  • Extensive knowledge of mechanical component, part and assembly design and fabrication. Working knowledge of electrical design is a plus.
  • Broad knowledge/experience with common manufacturing/fabrication processes including, but not limited to, injection molding, sheet metal, extrusion, solvent bonding, ultrasonic welding, RF forming/welding, thermoforming, pad printing, and other relevant medical device processes.
  • Ability to communicate effectively at all levels of personnel.
  • Computer literate and ability to use major software tools including proficiency with CAD programs (SolidWorks preferred). Knowledge of statistical techniques.
  • Possess above average technical writing, analytical, and communication skills. Ability to communicate complex problems for understanding to non-technical personnel. Ability to effectively communicate with clinicians and health professionals in the field.
  • Must demonstrate initiative and require minimal supervision. Self-starter with results driven characteristics.
  • Detail oriented and ability to organize large amounts of work and data. This includes the need for good documentation practices.
    • Knowledge of Good Lab practices equipment and hazards, upkeep, and handling of biologic mediums.
  Duties:
  • Lead creation of customer and product requirements and specifications.
  • Ability to develop and communicate understanding of clinical needs, product opportunities, and technology direction to project team.
  • Support marketing and clinical assessment on new products and concept initiatives. Define unmet needs and clinical pathway to address device opportunities.
  • Analyze the competitive landscape, customer and market trends, and product requirements as part of new product development processes.
  • Support collaborative ideation through concept development, prototyping, and feasibility studies.
  • Detailed design activities including 3D modeling and develop technical drawings, data sheets, and schematics.
  • Supports design for manufacturing activities including final part/assembly design, manufacturing process design, manufacturing assembly procedures and manufacturing testing procedures.
  • Participates in the safety hazard/risk analysis on products/systems, collaborating with the risk manager and other engineering disciplines.
  • Perform design verification and validation activities which meet all necessary requirements of a project, including drafting qualification documents ranging from equipment qualification to product validation.
  • Understand and execute all aspects of Design Controls during product and/or process development projects.
  • Understand quality system requirements of customers, FDA, QSR, and other regulatory agencies, and use quality tools to improve processes and products within those standards.
  • Design and implement test and simulation instrumentation, equipment, and procedures, utilizing the principles of engineering and biomedical sciences in development of medical devices related to Cardiovascular Surgery, Ophthalmology, Infusion Therapy, and other applicable markets.
  • Advise and assist in the application of instrumentation in clinical environments to support existing product lines and new product development.
  • Select and develop appropriate test tools, applying the latest techniques in testing and verification e.g., data-driven testing and clinical simulations.
  • Participate in the Change Control process to identify the quality implications and impact of proposed changes to product performance via the testing process.
  • Coordinate and lead project design reviews with emphasis on gap/risk analysis to ensure projects meet predetermined goals and objectives.
  • This individual will be part of a larger product development team and/or lead a small/moderate product development team based on complexity and skill sets.
  • This individual will be expected to solve technical issues and resolve problems/delays associated with projects with minimal supervision from Manager.
  • Competencies and knowledge of time, task and project management will be necessary to provide cross functional team with accurate and precise estimates for assigned task duration, along with confidence levels and foreseeable dependencies.
  • Assist the Manager in preparing project plans, budgets, and schedules.
  • Provide technical guidance to technicians, interns, and cross-functional team members assigned to product and process activity relating design, testing, and documentation.
  • Proactively address and work with Manager on daily issues associated with GMP, Safety and enhancing testing infrastructure at Quest.
  Notables / Benefits:
  • Summer hours available
  • Mid-size company with great company culture that is well diverse
  • Have a voice in the company
  • Average tenure for employee population is 7+ years
  • 401k with employee matching available
  • Paid vacation, health/vision/dental, and other excellent benefits
  An Equal Opportunity Employer    

Job Features

Job Category

Engineer, R&D

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensur...

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FullTime
Allen, TX
Posted 2 weeks ago
As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.     Position:  Manager, Advanced Process Engineering   Department:  Advanced Process Engineering   Reports to:  VP of Engineering / R&D   Summary: Responsible for managing sustaining engineering, process development, and product design improvement efforts, including managing the financial and technical resources to accomplish high sustaining engineering support levels, advancement of process development through new technology, and product design improvement projects.  Responsible for all plant sustaining engineering resources and projects.  Core deliverables include production support, product/process improvements, cost reduction, and CAPA support.   Responsible for long-term development of new manufacturing technology, automation, and machine integration.  Focus on employee development to build strong teams and a pipeline of talent.  Focus on technology development to improve manufacturing processes and maintain position as a competitive position as a US-based manufacturer.   Qualifications:
  • Bachelor degree in an engineering or technical discipline.
  • At least 7 years professional work experience in a manufacturing or engineering role and 3 years management experience in the medical device industry.
  • Strong project management skills and the ability to prioritize and manage multiple tasks simultaneously; PMP certification is desirable.
  • Lean Six Sigma Green Belt or higher. Six Sigma project management is a plus.
  • Strong working knowledge of medical device manufacturing process including cleanroom assembly, electronics assembly, injection molding, extrusion, ultrasonic welding, RF forming/welding, solvent bonding, adhesive bonding.
  • Excellent problem-solving and decision-making abilities, with a focus on continuous improvement.
  • Demonstrated experience with Root Cause Analysis and DOE.
  • Experience designing and developing process design requirements, and validating processes and equipment to meet those requirements. Demonstrated experience with automation equipment and PLC programming software is preferred.
  • Advanced computer skills using MS Office applications, SolidWorks (or other 3D modeling software) and Minitab statistical analysis.
  • Excellent writing, technical, and problem solving skills in the necessary engineering disciplines.
  • Knowledge of FDA, ISO 13485, and EU MDR requirements.
  • Excellent interpersonal skills to collaborate effectively with cross-functional teams and communicate with all levels of the organization.
  Responsibilities:
  • Plan and manage financial and personnel resource priorities for sustaining engineering projects to meet established company goals.
  • Actively manage engineering personnel to attain individual professional growth in areas of engineering, manufacturing, quality, safety, project management and clinical application by providing the motivation and opportunity to obtain further training.
  • Provide on-going engineering support to resolve component, process, design or equipment problems affecting production or quality; coordinate the execution of specific projects intended to improve efficiency and quality, increase capacity and reduce costs. Facilitate product improvement opportunities through the identification and assessment of high quality, cost competitive suppliers and process improvements.
  • Develop a project-based operating plan and yearly budget.
  • Responsible for implementing design control activities and for ensuring all project activities are compliant with domestic and international design control regulations.
  • Work closely with R&D, Sales, Marketing, and Quality to support new product development efforts. Provide technical leadership within the design transfer and manufacturing start-up stages of NPD.
  • Provide technical resources to Marketing in support of customer training, problem resolution and new project identification.
  • Manage all aspects of process automation and new manufacturing technology program transitioning to world-class manufacturing supporting safety, quality, delivery and cost. Develop in-depth financial and technical analysis to define and support long-term direction of new manufacturing technology program & strategy.
  • Collaborate with engineering, maintenance & manufacturing teams to ensure optimal functionality and availability of manufacturing equipment and facilities. Identify equipment needs, evaluate new technologies, and make recommendations for equipment upgrades or replacements to improve efficiency and capacity.
  • Establish and monitor department KPI's. Ensure teams take appropriate countermeasures to resolve and deficiencies.
  • Support Lean initiatives through participation on Kaizen Teams and adopt Lean principles into all process improvement activities. Provide leadership guidance and recommendations to the Continuous Improvement program.
  • Actively contribute to the CAPA program through leadership and guidance of cross-functional teams focused on customer complaint investigation and internal NCMR resolution.
  • Implement and actively enforce procedures that ensure that all products developed and marketed by Quest meet applicable domestic and international regulatory requirements.
  • Support supply chain processes through supplier evaluation, qualification and resolution of corrective actions. Provide technical support to the supplier audit team.
  • Develop, fabricate, qualify, and implement new process technology and equipment to support automation program.
  Notables / Benefits:
  • Summer hours available
  • Mid-size company with great company culture that is well diverse
  • Have a voice in the company
  • Average tenure for employee population is 7+ years
  • 401k with employee matching available
  • Paid vacation and other excellent benefits
  An Equal Opportunity Employer  

Job Features

Job Category

Engineer, Manufacturing, Process

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensur...

Apply Now

FullTime
Allen, TX
Posted 2 weeks ago
As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: Regulatory Affairs Manager – direct hire / full-time   Reports to: Director, Quality Assurance & Regulatory Affairs   Department: Regulatory Affairs   Location: Allen, TX 75002   Summary: Develops, implements, and maintains a comprehensive Quality & Regulatory Affairs system in accordance with regulatory requirements.  A highly participative leader, responsible for the hands-on management and direction of regulatory and document control personnel and for implementing best practices, continuous improvement, and corrective/preventive actions as necessary. Provides regulatory guidance to multifunctional teams on strategic planning to support compliance with all applicable domestic and international medical device regulations.  The individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and Technical Files.  Ensures conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials, and post-market feedback.   Develops and implements organizational policies, plans and procedures to ensure best practices for Regulatory Affairs and Document Control.  Establishes and monitors systems to maintain documents and records.   Requirements:
  • Bachelor of Science degree in a relevant discipline required.
  • Minimum ten years of experience in medical device Regulatory Affairs, seven years in medical device Class II/III required. Candidates with 5+ years of practical experience in the regulated medical device industry may be considered if they possess an advanced degree in Regulatory Affairs or other related discipline.
  • Minimum 5 years of experience with project management.
  • Expertise in FDA QSR, ISO13485, EU MDR, Health Canada, and other applicable U.S. and International regulations, including experience auditing these requirements. Knowledge of Japanese, Australian, and Brazilian requirements strongly preferred.
  • Demonstrated knowledge of ISO 14971 and IEC 60601 preferred.
  • Experience with preparing and filing reportable events (MDRs) and Vigilance Reports.
  • Previous experience with FDA regulatory submissions and CE marking.
  • Experience interacting with regulatory bodies, such as the FDA and Notified Body.
  • Experience with the UL certification process preferred.
  • Excellent prioritizing, organizational, and interpersonal skills. Ability to handle multiple projects simultaneously.
  • Must possess technical writing, project management and fundamental problem-solving skills.
  • Ability to review and provide critical feedback on design documentation.
  • Excellent writing and communication skills. The individual should be detail-oriented and have good deductive and problem solving skills.  Due to the requirements of a quality assurance environment, a certain degree of initiative and good mechanical aptitude would be advantageous.
  • RAPS RAC (US) preferred.
  • ASQ certification as a Certified Quality Auditor (CQA) preferred.
  Responsibilities:
  • Manages the personnel activities of the Regulatory Affairs and Document Control departments, including recommendations related to resource needs, training, and personnel development. Provides feedback on staff performance via performance reviews, and mentorship to continually improve staff skills and effectiveness.
  • Reviews and assesses changes to global regulatory requirements and industry best practices, and facilitates implementation through new or revised Quality Systems processes.
  • Prepares regulatory strategies and maintains submissions for U.S. and International markets, including but not limited to 510(k)s and Technical Files, to ensure timely approval of devices and continued regulatory support of marketed devices.
  • Reviews and summarizes post-market surveillance feedback, such as customer feedback, adverse event reporting, customer surveys, trade shows, and publications.
  • Provides technical guidance and instruction to staff in relation to regulatory affairs and document control policies and procedures.
  • Evaluates and documents all alleged reportable events and field action reviews/assessments. Prepares and submits all MDRs and associated documentation to the FDA and adverse event reports to other countries within the required timeframes.  Follows-up, as required, for failure investigations associated with reportable events.  Interacts with the FDA and other regulatory authorities on all MDR or reportable events.
  • Maintains and prepares device registrations, listings, certifications, export certificates, and Declarations of Conformity.
  • Responsible for understanding and complying with current domestic and international regulatory requirements, including but not limited to FDA, European, Canadian, Australian, Japanese, and Brazilian requirements.
  • Acts as a Regulatory Affairs representative on core product development teams. Communicates regulatory requirements and impact of regulations to the development teams. Reviews design history files to ensure all regulatory requirements are being met.
  • Reviews and provides regulatory authorization for labeling, marketing literature, and protocols/ reports for compliance with regulatory requirements.
  • Evaluates, investigates, documents and communicates with both the FDA and/or other regulatory authorities on all product recalls. Writes all recall communications to the field and customers.  Documents and reconciles product inventory associated with recall.  Follows up with corrective action associated with recall issue.
  • Allocated resources to ensure department priorities are realized and budget goals are met.
  • Provides oversight of third party testing (UL, EMC, biocompatibility, sterilization assurance) as required.
  • Supports an effective internal audit program. Reviews processes for compliance to appropriate regulations and internal procedures.
  • Provides support for external audits conducted by Quest customers and regulatory authorities.
  • Oversees document control efforts to ensure compliance with domestic and international regulations and standards.
  • Contributes to the development and implementation of business operating plans.
  • Evaluates and implement new document control systems.
  Notables / Benefits:
  • Summer hours available
  • Mid-size company with great company culture that is well diverse
  • Have a voice in the company
  • Average tenure for employee population is 7+ years
  • 401k with employee matching available
  • Paid vacation, health/dental/vision, and other excellent benefits
    An Equal Opportunity Employer

Job Features

Job Category

Regulatory Affairs

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensur...

Apply Now

FullTime
Allen, TX
Posted 3 weeks ago
Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: Quality Engineer I – direct hire / full time (Multiple openings) Reports to: Director, QA/RQ or Quality Systems Manager   Department: Quality   Location: Allen, TX 75002   Summary: Responsible for maintaining and improving the quality management system.  Performs activities to support quality aspects of design and development, manufacture, and post-production of components and finished products.  Conducts Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implements correction actions to eliminate quality problems.  Provides support and leadership to teams focused on CAPA.  Supports supplier quality program by performing audits, managing supplier metrics, and managing supplier correction action plans.  Develops various product tests and conducts data analysis.  Develops qualification test protocols and generates reports as needed.  Provides guidance on engineering projects. Supports the internal and external quality audit program. Uses statistical tools to analyze data, make acceptance decisions, and improve proves capability.   Requirements:
  • Bachelor of Science degree in a technical area such as science, engineering, math or equivalent experience
  • A minimum of 2 years of experience in a quality role in a regulated industry such as medical device or pharmaceutical is preferred.
  • Familiarity with FDA Quality System Regulation, MDD, ISO 9001, ISO 13485, and ISO 14971 is preferred
  • Strong unbiased advocate of compliance
  • Ability to work efficiently in a team environment
  • Must possess technical writing, project management, and fundamental problem-solving skills
  • Experience using word processing, spreadsheet, data management and/or design of experiments
  • Prior experience in auditing is desired
  • Previous experience performing laboratory and/or mechanical testing required
  • Excellent strong verbal and written communication skills
  • Ability to travel up to 10% of the time
  Responsibilities:
  • Support daily manufacturing activities and work with Engineers to resolve line issues and implement corrective actions.
  • Provide technical support for incoming inspection and lot release testing activities.
  • Provide support and leadership to Product Improvement Teams as Quality Engineer.
  • Manage customer complaint investigations from initiation through investigation and closure. Ensure reportability assessments are made in a timely manner for each complaint.  Ensure quality, in-depth investigations are performed, including effective root cause and corrective action assessments.
  • Manage NCMR investigations from initiation through investigation and closure. Perform product dispositions in a timely manner.  Ensure quality, in-depth investigations are performed, focusing on elimination of the defect condition through effective root cause and corrective action problem solving techniques
  • Provide input to the Supplier Quality program by evaluating potential suppliers, managing supplier corrective actions, performing supplier audits, and evaluating quality metrics.
  • Support the Internal Audit program by auditing, identifying and correcting deficiencies, creating reports, and conducting verifying effectiveness of corrective actions
  • Provide quality engineering support to engineering project teams associated with new product development projects or process improvement projects
  • Revise quality system procedures (SOPs and WIs)
  • Write protocols and coordinate the testing for validation activities, component qualification activities, IQ/OQs, test method validations, and Gage R&R studies.
  • Develop and maintain risk management files and quality control plans for components, devices and processes.
  • Provide training and/or technical guidance to QA Technicians and production staff as required.
  • Uses statistical analyses and interpretations for investigations, specification setting activities, and test protocols.
  • Participate in inspections with FDA, ISO, MDD, MDSAP and other regulatory agencies.
  • Support major quality projects which result in CPAR files
  • Use effective problem solving techniques to support successful completion of job duties.
  • Strive to constantly innovate and implement improvements for improved methods for testing components.
  • Works under general supervision. Relies on instructions and pre-established guidelines to perform the functions of the job.
  Notables / Benefits:
  • Summer hours available
  • Mid-size company with great company culture that is well diverse
  • Have a voice in the company
  • Average tenure for employee population is 7+ years
  • 401k with employee matching available
  • Paid vacation, health/dental/vision, and other excellent benefits
  An Equal Opportunity Employer  

Job Features

Job Category

Engineer, Quality

Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncol...

Apply Now

Intern
Allen, TX
Posted 4 weeks ago
As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: Electronics Engineering Intern – 14 weeks   Reports to: Electronics Engineering Supervisor   Department: Electronics Engineering   Location: Allen, TX 75002   Summary: Provide technical support to the engineering staff. The position supports activities associated with manufacturing support, process improvement, validation, QA systems, and product development. The position is expected to work approximately 40 hours a week between Monday and Friday. The days and time of work required to fill this schedule are flexible to fit the student’s academic commitments.   Requirements:
  • Detail oriented and possess a professional demeanor, be adaptable to changing environments, handle diverse workloads, and capable of completing tasks with little or no supervision.
  • Ability to read and interpret engineering drawings, product specifications and procedures, and use metrology and test equipment.
  • Computer skills including MS Excel, MS Word, MS Project (basic knowledge of each).
  • Desirable to have engineering specific computer skills such as: SolidWorks, Minitab, MATLAB, LabVIEW (basic knowledge level. The software package may be dependent on the position).
  • Good written and oral communication skills are required and must be able to read, write, and understand English.
  • Shall have experience in data analysis, statistics, and understanding of engineering principles.
  • Continuing education on an undergraduate or graduate degree program in an engineering or scientific discipline.
  Duties:
  • Execute engineering activities under supervision of an Engineer.
  • Perform visual and dimensional inspection of components, in-process subassemblies and finished products.
  • Prepare samples, perform functional tests, and execute validation activities using various equipment and test methods according to protocol requirements and standard testing procedures.
  • Document inspection/testing results and perform basic statistical analysis.
  • Perform data input (MS Excel), statistical analysis, and format spreadsheet information for inclusion within test reports.
  • Draft basic qualification protocols and reports.
  • Draft engineering change orders to support engineering activities.
  • Coordinate all testing activities with responsible Engineer.
    An Equal Opportunity Employer  

Job Features

Job Category

Electrical, Engineer, Internships

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensur...

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Intern
Allen, TX
Posted 4 weeks ago
As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets.  Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery.  Our company culture is very diverse and the average tenure for our employee population is 7+ years.  If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.     Position: R&D Engineering Intern – 14 week Summer Program   Reports to:  R&D Engineering Manager   Department: R&D   Location: Allen, TX 75002 Summary: Providing technical support to the engineering staff and preparing technical reports, summaries, protocols, and quantitative analysis. Support and collaborate with the R&D team on various projects.   Qualifications:
  • Pursuing a Bachelor of Science degree in a technical field such as biomedical engineering, polymer science, chemistry, chemical engineering, mechanical engineering or other engineering field is required.
  • Ability to communicate effectively at all levels of personnel.
  • Computer literate and ability to use major software tools (MS Office) including 3D CAD programs (SolidWorks preferred).
  • Knowledge of statistical techniques.
  • Possess above average technical writing, analytical, and communication skills. Ability to communicate complex problems for understanding to non-technical personnel. Ability to effectively communicate with clinicians and health professionals in the field.
    • Knowledge of Good Lab practices equipment and hazards, upkeep and handling of biologic mediums.
  Responsibilities:
  • Participate in Voice of Customer activities to develop customer and product requirements and specifications.
  • Ability to research clinical applications of various medical devices to develop and communicate understanding of clinical needs, product opportunities, and technology direction to project team.
  • Analyze the competitive landscape, customer and market trends, and product requirements as part of new product development processes.
  • Support collaborative ideation through concept development, prototyping, and feasibility studies.
  • Assist in execution of testing protocols, gather and organize data and prepare technical reports.
  • Design and implement test and simulation instrumentation, equipment, and procedures.
  • Support ongoing development projects for R&D Engineers throughout various phases of development.
  An Equal Opportunity Employer

Job Features

Job Category

Engineer, Internships, R&D

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensur...

Apply Now

Intern
Allen, TX
Posted 4 weeks ago
As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets.  Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery.  Our company culture is very diverse and the average tenure for our employee population is 7+ years.  If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.     Position: Process Engineering Intern – 14 week Summer Program   Reports to:  Advanced Process Engineering Manager   Department: Advanced Process Engineering   Location: Allen, TX 75002   Summary: Supports daily manufacturing operations and activities associated with process improvement, validation, QA systems, and technology/product development.   Qualifications:
  • Working towards an undergraduate or graduate degree in a relative Engineering program.
  • Ability to communicate effectively both written and orally.
  • Computer literate and possess ability to use major software tools.
  Responsibilities:
  • Perform duties and responsibilities under the direct supervision and leadership of the Process Engineering Manager and/or senior engineering personnel.
  • Identify, justify and implement equipment upgrades, new product and process technologies, and process improvements.
  • Understand basic requirements of design control during product and/or process development projects.
  • Understand quality system requirements of customers, FDA, QSR, and other regulatory agencies, and use quality tools to improve processes and products within those standards.
  • Perform analysis of data and reports results in a technical report.
  • Perform root cause analysis and recommends resolution of problems associated with products, manufacturing processes, and customer complaints.
  • Perform design verification and validation activities which meet all necessary requirements of a project, including drafting qualification documents ranging from equipment qualification to product validation.
  • Manage complaint investigation activities for required product lines consisting of failure investigation, root cause analysis, and corrective and preventative action implementation for complaint issue.
  • Draft engineering change order reports and non-conforming material reports.
  • Support, coordinate, and/or lead projects requiring cross-functional team participation to meet project goals.
  • Possess technical writing, project management and fundamental problem-solving skills.
  • Able to apply advanced mathematical concepts and statistical analysis.
  • Provides support role for senior engineering personnel in all aspects of medical device manufacturing engineering.
  An Equal Opportunity Employer

Job Features

Job Category

Engineer, Internships, Process

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensur...

Apply Now

Intern
Allen, TX
Posted 4 weeks ago
As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: Quality Engineering Intern – 14 week Summer Program   Reports to: Quality Engineering Manager   Department: Quality   Location: Allen, TX 75002   Summary: Learn quality management operations and quality controls methods in manufacturing.  This candidate will work in collaboration with the Quality Engineering team on various projects.  He or she will make detailed observations, analyze data, and interpret results.  Candidate will prepare quality management documentation, prepare technical reports, and conduct quantitative analyses.   Requirements:
  • Currently enrolled student majoring in Biomedical Engineering or related field that has completed freshman year courses.
  • Minimum 3.0 GPA
  • Good verbal, written, and interpersonal communication skills for effective interface with all contacts.
  • Ability to work effectively with others and be a participative team player.
  • Good organizational ability and attention to detail.
  • Authorized to work in U.S.
  • Comfort with group/individual presentations.
  • Intermediate knowledge and experience in Microsoft Office programs, including Word, Excel, PowerPoint and Outlook.
  Duties:
  • Adhere to and ensure compliance with Quality System objectives (SOPs, work instructions, drawings, technical documentation, current Good Manufacturing Practices (cGMPs)).
  • Collect, analyze, trend and communicate quality data.   Self-checks work for completeness and accuracy.
  • Support improvement initiatives in the quality management system throughout organization (NCMRs, Complaints, CAPAs, ECOs).
  • Assist the Quality Engineer with Corrective and Preventive Action (CAPA) activities (root causes, investigations, implementations of corrective actions and completion).
  • Write and revise quality systems documentation (SOPs, work instructions, test procedures)
  • Perform testing under guidance to support validation activities, component qualification activities, IQ/OQs, test method validations, and Gage R&R studies.
  • Creates Engineering Change Order documentation under the guidance of Quality Engineer.
  • Works under general supervision of the Quality Engineer, QMS Manager, and / or other personnel as assigned.  Relies on instructions and pre-established guidelines to perform the functions of the job. Assumes additional responsibilities as necessary at the discretion of QA.
An Equal Opportunity Employer  

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Job Category

Engineer, Internships, Quality

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensur...

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FullTime
Allen, TX
Posted 4 weeks ago
As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: Senior Maintenance Technician   Reports to: Facilities Supervisor   Department: Facilities   Location: Allen, TX 75002   Summary: Responsible for performing specific maintenance tasks required to maintain manufacturing, support, and facility equipment.  Provide high service level to Operations to ensure reduction in downtime and high equipment efficiency.   Requirements:
  • High school diploma or equivalent
  • Associate Degree / Trade School Certificate and a minimum of 10 years manufacturing related maintenance experience
  • High levels of mechanical aptitude and knowledge of the installation, maintenance and repair of manufacturing equipment such as motors, pumps, conveying systems, hydraulics, and pneumatics. Ability to troubleshoot and repair mechanical, electrical, pneumatic, and hydraulic equipment.
  • Knowledge of Word, Excel, and Outlook
  • High level of knowledge on PLC operation, control systems, and troubleshooting
  • High level of knowledge on robot operation and troubleshooting
  • Good organization skills and attention to detail
  • Strong customer service orientation along with solid analytical and problem solving skills
  • Good verbal and written skills
  Duties:
  • Perform equipment preventative maintenance activities and ensures completion of associated documentation
  • Provide timely and effective maintenance of manufacturing equipment to reduce downtime and ensure high equipment productivity
  • Provide support to projects associated with the new equipment or new fixtures, such as design, fabrication, and feasibility work
  • Perform unscheduled equipment maintenance activities and ensure completion of associated documentation
  • Perform technical troubleshooting of advanced manufacturing assembly equipment, including automation and robotic equipment. Detect faulty operations, defective raw material and report those and any unusual situations to proper supervision
  • Read and interpret equipment manuals and work orders to perform required maintenance and service
  • Use a variety of hand and power tools, electric meters and material handling equipment in performing duties.
  • Use shop equipment such as CNC mill, lathe, milling machine, band saw, etc. to fabricate parts for machines, fixtures, or product modification
  • Maintain facility systems as required, including normal repair activities
  • Perform emergency and/or detailed custodial duties
  • Perform other miscellaneous duties as directed by the Facilities Supervisor
  • Comply with safety regulations and maintain clean and orderly work areas
  Notables / Benefits:
  • Mid-size company with great company culture that is well diverse
  • Have a voice in the company
  • Average tenure for employee population is 7+ years
  • 401k with employee matching available
  • Paid vacation and other excellent benefits
  An Equal Opportunity Employer  

Job Features

Job Category

Maintenance

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensur...

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FullTime
Allen, TX
Posted 4 weeks ago
As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: Field Service Technician – 2nd Shift   Reports to: Quality Ops Manager / Field Service Supervisor   Department: Field Service   Location: Allen, TX 75002   2nd Shift Schedule: 5:30 PM – 4 AM / Monday through Thursday   Summary: Perform customer support activities, both in-house and at the customer site, involving the installation, preventive maintenance and repair of the Quest Medical instrumentation.   Requirements:
  • One or more years of experience in troubleshooting and repair of electronic/electro-mechanical assemblies of medical devices or instruments or equivalent repair and service activity.
  • Ability to work in a teamwork setting and as an individual contributor.
  • Experience in dealing with internal and external customers.
  • Computer skills using Microsoft Word, Excel, and the ability to work remotely.
  • Ability to use standard field service engineer’s tools sets (scope, DMM, DVM).
  • Ability to lift up to 65 lbs.
  Preferred:
  • ESD Experience
  • Soldering experience
  • FDA/ISO Regulated environment experience
  Responsibilities:
  • Isolate instrument malfunctions and take corrective action in the form of repair.
  • Ensure all customer and Service instruments are in good working order.
  • Represent Quest Medical in dealings with customers and is responsible for customers’ satisfaction with the MPS instrument.
  • Support inside service department in processing instrumentation.
  • Communicate all service/repair activity with customer (as necessary), Field Service leadership, and other applicable Quest Medical team members.
  • Provide feedback on improved methodologies for repair and maintenance tasks.
  Notables / Benefits:
  • Mid-size company with great company culture that is well diverse
  • Have a voice in the company
  • Average tenure for employee population is 7+ years
  • 401k with employee matching available
  • Paid vacation, health/dental/vision, and other excellent benefits
    An Equal Opportunity Employer

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Job Category

Field Service

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensur...

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FullTime
Allen, TX
Posted 1 month ago
As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: Material Handler II – direct hire / full time   Reports to: Warehouse Supervisor   Department: Materials   Location: Allen, TX 75002   Summary: Perform routine and non-routine functions and related clerical duties in the areas of material handling, warehousing, kitting, receiving, and shipping. Plan and perform a variety of operations, processes, and make general decisions as to quality. Understand all applicable Standard Operating Procedures. Provide instruction, training, and leadership to Material Handler. Work with a minimum amount of supervision.   Requirements:
  • High school graduate or equivalent plus one year job related experience.
  • Ability to read, write, compare numbers, perform basic math tasks and understand detailed oral and written instructions.
  • Ability to recognize and associate name with material and part number.
  • Knowledge of warehouse locator system and material movement procedures.
  • Ability to analyze and compare data to exercise judgement in order to make decisions.
  • Ability to pay attention to detail and meet deadlines.
  • Experience using forklifts, pallet jacks, hand trucks, and other material handling equipment.
  • Capable of continuous walking, standing, and lifting of materials up to 50 lbs.
  • Must have a good driving record and a valid Texas driver’s license.
  • Must wear safety shoes and back support belt.
  • Ability to use a calculator and computer.
  Duties:
  • Perform Material Handler responsibilities as required.
  • Identify any deviations from established procedures such as inappropriate material movements, improper authorization, and incomplete paper work.
  • Monitor and maintain proper product separation and segregations.
  • Maintain material flow and related computer transactions.
  • Maintain inventory accuracy through routine cycle counts.
  • Identify procedures that can be improved and recommend changes.
  • Provide Inventory Control and Planner Manager with monthly reports on warehouse activities and performance.
  • Review all procedures quarterly and advise supervisor of needed or recommended changes.
  • Interface with internal and external customers and vendors.
  • Responsible for maintaining warehouse records.
  • Responsible for assuring all warehouse equipment is in good working order.
  Notables / Benefits:
  • Mid-size company with great company culture that is well diverse
  • Have a voice in the company
  • Average tenure for employee population is 7+ years
  • 401k with employee matching available
  • Paid vacation and other excellent benefits
  An Equal Opportunity Employer

Job Features

Job Category

Warehouse

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensur...

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FullTime
Allen, TX
Posted 1 month ago
As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: Vice President of Operations   Reports to: President   Department: Operations   Location: Allen, TX 75002   Summary: Lead and direct manufacturing, sustaining engineering, maintenance/facilities and supply chain operations in the achievement of the Company’s long-term operational and strategic growth objectives while facilitating a continuous improvement environment. Provide effective leadership to management personnel and achieve employee growth and development.  Advance technology within the manufacturing facility and maintain a LEAN culture to stay competitive in the medical device market.  Lead team to achieve Operating efficiency goals and manage long-term Operational profitability initiatives for the company. Ensure Operational commitment to new product development projects and provide cross-functional leadership on a R&D steering committee. Oversee the company facility.  Key member of the Company’s Senior Leadership Team.   Requirements:
  • Bachelor of Science in a technical discipline, preferably in Engineering or Operations Management.
  • A minimum of 15 years total of experience in a regulated industry (preferably the medical device industry), including a minimum of 10 years of department management experience. Experience in both Operations and Engineering needed.
  • Strong technical problem solving skills and experience with manufacturing system/process development
  • Significant experience with computerized manufacturing management systems, methods, and philosophies, an in-depth knowledge of computer-based MRP systems, controls and capabilities.
  • Experience, awareness and understanding of contemporary manufacturing concepts and philosophies including LEAN
  • Strong planning, budgeting and cost management systems experience.
  • Experience in planning and introduction of new products from various sources into the manufacturing line. Experience in managing effective Sustaining Engineering teams.
  • Excellent technical writing experience preferably within a medical device environment.
  • Excellent working knowledge of the Quality System Regulations and preferably Medical Device Directive
  Responsibilities:
  • Provide leadership, supervision, mentoring, and development of department managers and support staff in the following areas: Manufacturing, Sustaining Engineering, Supply Chain, Facilities, and Maintenance.
  • Identify and develop department talent to support effective performance management and continuous employee development. Strive to develop strong cross-functional leaders within department.  Foster an atmosphere of teamwork through employee collaboration and involvement.
  • Maintain front-line responsibility for operating efficiency and excellence. Manage, improve, and achieve operating profitability as part of manufacturing operations.   Use a data and results focused approach to managing daily operations.
  • Identify and implement long-term cost reduction and containment initiatives to ensure long-term success in highly competitive markets. Collaborate with Sales, Marketing, and R&D personnel to focus on reduction of standard costs of key products to improve potential for long-term growth.
  • Work closely with the President and management team to plan and achieve the current and long-term strategic objectives of the Company. Apply strong operations management techniques and implement long-term business improvements through strategic thinking and positioning.
  • Develop and maintain annual and future manufacturing plans that support the Company’s overall long-term strategic plan. Focus on understanding future needs for manufacturing processes, technology, and capacity.  Anticipate future obstacles, generate and implement strategic plans to align with Company goals.
  • Develop annual Department Goals in all key areas. Achieve goals by reviewing performance expectations regularly and providing informal/formal feedback continuously.  Ensure goals are communicated throughout all levels of the company.
  • Develops and manages budgets for all assigned departments.
  • Continuously manage, develop and apply key metrics to reduce/minimize variances, reduce/control standard costs, provide periodic reports, and collaborate with senior management team to identify areas of cost reduction/containment focus.
  • Lead and promote emphasis on quality in all aspects of manufacturing, training, manufacturing engineering and facilities/maintenance processes. Demonstrate through leadership consistent involvement and by using the key processes of problem solving and continuous system improvement.
  • Lead Lean implementation and transformation to ensure that the concept of Lean Principles are deployed and reinforced throughout manufacturing to support the Company’s goals.
  • Provide leadership and direction to implement SMART Factory and Industry 4.0 initiatives to ensure company maintains its position as a successful, competitive US Manufacturer.
  • Provide strategic leadership to Engineering teams to ensure selection of impactful projects, efficient productivity, and implementation of strong Engineering principles during all projects. Provides management and oversight for planning, organization, and attainment of performance goals, priorities, and objectives.  Serve as management liaison between Production and Engineering when needed.
  • Establish and implement effective metrics to analyze and make decisions on key metrics on a real-time basis. Publish metrics on a frequent basis.
  • Collaborate with Sales and Marketing, R&D, and Quality to support new product development efforts from a manufacturing and sustaining engineering perspective. Provide cross-functional leadership on a R&D Steering Committee.
  • Ensure that manufacturing processes meet compliance requirements (FDA, EU, etc.) and are consistent with company’s Quality Management System requirements.
  • Provide department representation to the Product Improvement Teams with the overall goal of effective problem resolution resulting in improvement of key quality metrics for complaints and NCMRs
  • Provide oversight and key management for Buildings and Grounds, including long-term expansion and capacity resolution.
  Notables / Benefits:
  • Mid-size company with great company culture that is well diverse
  • Have a voice in the company
  • Average tenure for employee population is 7+ years
  • 401k with employee matching available
  • Paid vacation, health/dental/vision, and other excellent benefits
  An Equal Opportunity Employer  

Job Features

Job Category

Engineer, Manufacturing, Operations

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensur...

Apply Now

FullTime
Allen, TX
Posted 2 months ago
As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.     Position:  Purchasing Manager   Department:  Materials Management   Reports to:  Director, Supply Chain   Summary: The Purchasing Manager is responsible for leading a team of procurement professionals who execute business strategies by providing analytical, project management, and tactical executional support, and act as Ambassadors of Progress within Quest Medical.  The ideal candidate will lead the procurement, sourcing and supplier management for direct and indirect purchasing, collaborate with internal and external stakeholders to develop procurement strategies, analyze data concerning market condition, procurement & sourcing activities to mitigate risk, negotiate with suppliers, manage contracts and improve overall supplier management.   Qualifications:
  • Bachelor’s degree in Business, Finance, Operations, Supply Chain, or related field from an accredited university
  • Minimum 10 years’ experience in supplier management, negotiation, contract management. Risk mitigation and cost saving.
  • Minimum of 5+ years as a supervisor or manager, or as leader of cross-functional project teams.
  • Strong systems knowledge. Experience working with ERP systems: SAP, Oracle and/or J.D. Edwards
  • Computer literate in Word, Excel, and PowerPoint.
  • Proven ability to manage multiple tasks and meet challenging deadlines, lead a team of professionals, and solve problems, both quantitative and qualitative.
  • Working knowledge and experience of procurement and best-in-class practices, principles, process, tools and methodologies
  • Demonstrated strong business judgment and critical thinking to create and evaluate innovative options and use a fact based decision making process to develop and implement strategies that will drive positive results and deliver value
  • Strong leadership, communication, and organization skills.
  • Strong negotiating skills
  • Ability to travel up to 15%
  • Prefer Medical Device Manufacturing experience
  • Strong critical thinking, problem solving, and analytical skills;
  • Excellent communication and people skills.
  • Process orientation with an enterprise mindset.
  • Strong Project Management skills
  • Professional certifications desirable (CPSM, CPM, PMP or similar certification)
  Responsibilities:
  • Leading site procurement team and initiating and fostering relationships with site stakeholders, establishing and prioritizing activities for the team to achieve objectives and results
  • Develop sourcing, and procurement strategies to optimize annual spend; Monitor and analyze spend performance and spend data to forecast, assess market trends and develop procurement process and sourcing strategies to achieve cost reductions for commodities and categories. Ensure optimal balance between value for money and cost savings is achieved, while ensuring quality and good customer service.
  • Lead supplier selection, sourcing, and award business to optimize Supplier Portfolio Strategy based on demand and risk. Identifying potential suppliers and evaluating their capabilities, capacity, and reliability to meet organizational needs.
  • Manage supplier contracts, conduct contract review and audit, negotiate, and renew contracts with suppliers to align with market trends, drive cost saving and improve commercial conditions.
  • Optimize cash by extending supplier payment terms and/or negotiating term discounts and optimize the supply base through consolidation, where appropriate. Delivering year-over-year PPV savings.
  • Develop and execute commodity negotiation strategies with suppliers, including specific targets for pricing, service, quality, intellectual property, tool ownership, etc.
  • Lead strategic efforts, internally and externally, to improve supplier service and material availability
  • Minimize impact of supplier shortages by proactively identifying and resolving potential material supply issues, timely communication, collaborating with Planning and Manufacturing for inventory build, and proper escalation.
  • Maintain and monitor inventories to ensure levels are sufficient to meet both internal and external customer needs.
  • Drive proactive procurement involvement in the Innovation planning processes with R&D.
  • Serve as an escalation point for manufacturing and planning to secure on-time deliveries
  • Utilize procurement tools including J.D. Edwards, ReportsNow, and Monday.com to interact with data, to extrapolate insights and assess trends, and to make recommendations for improvement. Responsible for the effective execution and accuracy of MRP and related system processes
  • Develop and monitor performance of suppliers to Quest Medical KPIs, including First Pass Yield and On-Time/In-Full Delivery, and Overall Cost. Implement corrective actions as necessary to ensure adherence to quality standards and delivery timelines
  • Follow all Quest Medical policies and procedures and exemplify Quest Medical core values of Inspiring Solutions that Treat People Better by Empowerment, Innovation, Teamwork & Collaboration, Speed & Purpose, Growth, and Fun
  • Nurture stakeholder and supplier relationships by serving as a business partner.
  • Responsible for people leadership. Recruit, mentor, train and develop talent. Confronts and deals with people issues in a constructive and timely manner. Responsible for overall morale of team and promotes cohesive attitude. Execute against established staffing/resources plan.
  • Represent Procurement on key activities that have an impact on the performance of the business
  • Provide insights and mapping of Supply Chain capabilities and demand to effectively manage risk
  Notables / Benefits:
  • Summer hours available
  • Mid-size company with great company culture that is well diverse
  • Have a voice in the company
  • Average tenure for employee population is 7+ years
  • 401k with employee matching available
  • Paid vacation and other excellent benefits
  An Equal Opportunity Employer    

Job Features

Job Category

Purchasing

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensur...