Open Position

FullTime
Allen
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 10+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be Summary: The Sr. Quality Assurance Manager leads the Quality Operations and Quality Engineering teams to ensure exceptional product quality and regulatory compliance. This role involves strategic project management to balance multiple projects with competing priorities. Key responsibilities include developing Quality Control Plans, utilizing data to enhance Quality Control and CAPA operations, and validating test methods. The manager reviews and approves critical documents such as Device History Records, SOPs, Validation Protocols, Deviation Reports, and CAPA Reports to ensure operational support and compliance. Additionally, the Sr. Quality Assurance Manager manages environmental monitoring in production areas, oversees sterilization validation activities, and leads root cause analysis investigations for effective CAPA resolution. The role also involves qualifying and monitoring suppliers, deploying risk mitigations to ensure product safety, and participating in regulatory inspections and customer audits. Continuous innovation and improvement of testing methods and processes are essential aspects of this position. General Duties and Responsibilities: • Manages and develops the Quality Operations and Quality Engineering leadership staff. • Utilize project management strategy at a department level to successfully execute multiple projects with competing resources and prioritization • Develops effective Quality Control Plans to assure world-class product quality. • Utilizes data as related to the Quality Control and CAPA operations. • Develops and validates test methods, performs data analysis, and writes/revises SOPs. • Reviews and approves documents, including Device History Records, Standard Operating Procedures, Validation Protocols and Reports, Deviations, Engineering Change Requests, and Non-Conforming Materials Reports, CAPA Reports, Complaint investigations and Supplier Corrective Action Reports to ensure operational support and compliance. • Manages the environmental monitoring program in applicable production areas, including sterilization validation and re-validation activities. • Leads root cause and failure analysis investigations to ensure effective CAPA resolution. • Continuously innovate and improve methods and processes. Defines optimum approaches in testing and analyzing data for each test being performed. • Acts as assistant to Management Representative during customer and regulatory audits. Participates in regulatory inspections and customer audits. • Qualifies new suppliers as needed and perform routine supplier monitoring activities. • Deploys effective risk mitigations to assure product safety and efficacy.   Qualifications: • Bachelor’s degree in a technical or scientific discipline is required. • A minimum of ten years of experience in a quality or regulatory position, preferably in the medical device industry. Experience with EO sterilization processes, sterile product assembly and packaging, and electronics assembly preferred. • A minimum of five years of management experience or 10 years in a quality leadership role. • Excellent working knowledge of the FDA’s 21 CFR Part 820; ISO 13485; EU Medical Device Directive (93/42/EEC); Canadian Medical Devices Regulation (SOR98-282); Japanese MHLW Ordinance 169; RDC ANVISA 16/2013, Australian TG(MD)R, ISO 14971, ISO 9001, and Medical Device Single Audit Program (MDSAP). Experience with IEC 60601 preferred. • Experience in supporting FDA inspections as a quality system subject matter expert and an ability to interpret regulatory 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. • Demonstrated ability to work in a highly cross-functional environment. • Excellent technical writing experience within a medical device environment is essential. • Strong root cause analysis skills. • Ability to use sound scientific judgement and risk management for the facility to prevent regulatory action. • The ability to work with minimal supervision to prioritize tasks and be able to manage several projects and tasks simultaneously to meet deadlines; and the ability to interface with all levels of management. • Certified Lead Auditor or ASQ certification as a Certified Quality Auditor (CQA), Certified Quality Engineer (CQE) strongly preferred. Why Join Us: 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 Quest Medical Inc. is an Equal Opportunity Employer committed to diversity in the workplace. Join us in shaping the future!

Job Features

Job Category

Quality, 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...

FullTime
Allen
Posted 1 month 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 10+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be. Summary: Responsible for using Materials Requirement Planning (MRP) logic and stated inventory practices to plan raw material and purchased components. Maintain all MRP related computer data files and places purchase orders with approved Suppliers. Share best practices with entire Purchasing Department. General Duties and Responsibilities: • Assist project team in implementation of new Enterprise Resource Planning (ERP) system related to the Purchasing Department. Make recommendations to improve system functionality, navigation, reporting, and data output. • Define, establish, and maintain best practices and standard operating procedures to manage the following Purchasing Responsibilities (both Electronics and Disposables): • Create Purchase Orders and Requisitions • Supplier Quality Management • Engineer Change Order (ECO) Process • Capital Equipment Purchases • Supplier Specification Approval (SSA) Process • Supplier Approval Process • Safety Data Sheets • Non-Conforming Material Report (NCMR) Process • Plan and process raw material orders by interpreting requirements. • Monitor RM inventory levels to meet corporate inventory valuation objectives. • Review purchase price variances for raw material purchases. • Prepare and distribute raw material purchase requisitions for management approval. • Process purchasing requisitions, entering correct information into system, conveying order information to approved suppliers and expediting orders as needed. • Process change orders to correspond to changing manufacturing requirements. • Monitor the Supplier Specification Approval (SSA) program for all raw material suppliers. • Administer the MRB function by communicating with suppliers for material return for credit or initiates scrap procedures. • Maintain all MRP and supplier-related computer data files. • Prepare bid packages on new and existing parts when specified. • Identify new suppliers as needed. Assist in SER program. • Research products and supplies of special products by establishing what the item is and what it will be used for and identify viable suppliers for that product. Evaluate product for serviceability, cost and quality and communicate information to the requisitioner so informed decisions can be made. • Maintain a professional attitude when contacting outside suppliers to promote the Total Quality Management Policy of the Company. • Maintain open lines of communication with all levels of management and personnel. • Analyze material usage, work in process, and manufacturing lead times to determine production schedules to assure a smooth production flow in meeting sales forecasts and customers’ order requirements. • Maintain and monitor inventories to ensure levels are sufficient to meet both internal and external customer needs. • Prepare and present various reports, summaries, and analyses of planning activities. • Assist in maintaining accuracy of MRP II database by arranging for the correction of errors and the addition of new information. Qualifications: • Bachelor’s degree or equivalent work-related experience. • 3 - 5 years of experience in a Purchasing/ Planning position. • Certified in Purchasing Management (CPM) or Certified in Production and Inventory Management (CPIM) preferred. • Computer literate in Word, Excel, and PowerPoint. • Strong communication and organization skills. Why Join Us: Mid-size company with great company culture that is well diverse Have a voice in the company Average tenure for employee population is 10+ years 401k with employee matching available Paid vacation and other excellent benefits An Equal Opportunity Employer

Job Features

Job Category

Purchasing

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...

FullTime
Allen
Posted 1 month 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 10+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be. Summary: Responsible for management of Purchasing and Production Planning. Responsible for analyzing sales forecasts, customer orders, and inventory levels to determine material requirements, production schedules, and to insure highest customer satisfaction metrics for on-time shipments. Responsible to monitor Purchase Price Variance and to identify and strategically drive improvements in material costs. Manage Purchasing and Scheduling staff. Active member of the company’s LEAN deployment and DEVELOPS teams, continually striving for advancement in methods to improve material acquisition, inventory improvements, and cost containment initiatives. Ensure timely receipt of materials for New Products. Focus on employee development to build strong teams of lifters and a pipeline of talent. Responsible for KPI reporting to SRLT and corporate finance. General Duties and Responsibilities: • Responsible for Inventory is controlled through a robust development and use of JDE tools. Ensure JDE inputs are accurate at all levels of the organization. • Responsible for identifying and changing inventory target levels depending on needs of the business and supply chain dynamics to ensure customer needs are being met for on-time delivery, minimizing backorder situations. Active collaboration with Leadership team. • Management of Purchasing and Planning resources using effective deployment tactics to ensure a high performance team to meet the company’s production requirements. • Applies LEAN initiatives to optimize material flow through the facility. Leads Kaizen teams to identify and eliminate inefficiencies in material flow, and inventory management processes. • Key member of the DEVELOPS team with leadership expectations. • Active member of the XLT Extended Leadership Team. • Evaluates and implements emerging technologies for inventory management and production planning. • Leads cross-functional team to ensure sales forecasts are translated and updated regularly for Purchasing and Operations to meet inventory targets. • Role will be asked to learn and become an SME for ERP system. • Utilize advanced techniques and mathematical solutions to establish and maintain the inventory control plan across all SKUs. • Analyze material usage, WIP, and manufacturing lead times to determine production schedules to assure a smooth production flow in meeting sales forecasts and customers’ order requirements. • Responsible for daily production planning, including front-end work order generation and back-end review of closed work orders. • Maintain forecast within the ERP system, and monitor performance against the forecast to assure inventory levels of both raw materials and finished goods are adequately maintained. • Lead quarterly forecast update meetings with all key personnel. • Maintain accurate perpetual inventory levels and records through the administration of the cycle count process. • Prepare necessary information for quarterly inventory obsolescence review meeting. • Manage negotiation of all freight contracts. • Ensure compliance to MAPs, SOPs, and QSRs within team functions. • Develop and manage with visual metrics for each department to ensure productivity and efficiency goals are being met. • Lead supplier development activities, including complex new supplier business relationships and performance improvements of existing suppliers to meet requirement. Includes team leadership during supplier audit programs. • Analyze, identify, and recommend action plans for long-term supply chain integrity to support the business. Identify secondary sourcing issues and execute supplier risk analysis processes. Qualifications: • Bachelor’s degree in related field plus 5 years of work-related experience in a manufacturing environment. • Experience with JD Edwards is desirable. • Advanced production planning capability using technology and mathematical techniques. • Experience in LEAN manufacturing environment, including demonstrated leadership preferred. • Computer literate in Windows, Word, Excel, and PowerPoint. • Minimum of 3 years or related supervisory experience. Why Join Us: Mid-size company with great company culture that is well diverse Have a voice in the company Average tenure for employee population is 10+ years 401k with employee matching available Paid vacation and other excellent benefits An Equal Opportunity Employer

Job Features

Job Category

Supply Chain

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...

FullTime
Allen
Posted 1 month 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 10+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be. Summary: Manage the Facilities Team to ensure effective programs are in place to support the production areas. Direct management of key building systems such as HVAC BAS, compressed air system, clean room, building security, housekeeping, and landscaping. Responsible for administration of the Metrology program for both in-house calibrations and managing external suppliers for calibration services. General Duties and Responsibilities: • Manage and provide training and direction for maintenance and facilities personnel. • Responsible to lead the EHS Program - Safety, Evacuations, Medical Response, Training, Etc. • Be an active, contributing member of the Management Team (XLT) to support company implementation of company’s core beliefs and continuous improvement activities. • Manage preventative maintenance and unscheduled maintenance programs for production equipment. • Monitor equipment issues, assign personnel for repair, and prioritize those issues on a daily basis to reduce production line downtime. Maintain equipment downtime system and implement actions to reduce equipment downtime. • Analyze equipment trends and modify preventative maintenance activities as required. • Maintain machine shop, including use of machine shop equipment to support production processes or equipment fabrication activities. • Identify new equipment needs, establish equipment requirements/specifications, and make recommendations regarding purchase of new equipment. • Maintain adequate inventories of production equipment spare parts. • Manages buildings and grounds maintenance activities, including contract vendors. • Manages monthly spending for buildings and grounds maintenance. • Manage calibration department, resources, and oversight of calibration schedule/database. • Manage and monitor performance of outside contractors such as, utilities, janitorial, landscape, security, electricians, pest control, waste disposal, and construction. • Lead facility renovation projects and ensure building map is kept up to date. • Responsible for waste disposal and recycling systems. • Ability to have administrator capability for software such as CMMS and calibration. Maintain building and key building systems including mechanical, electrical, plumbing, HVAC, compressed air, clean room, facility security, fire/life safety and grounds maintenance. • Directs maintenance of calibration database for tracking of items in the calibration program and daily tasks in the calibration software to ensure compliance to procedures and standards. • Manages external calibrations vendors for calibration of more advanced items. • Manages monthly spend to budget for external calibration vendors. Qualifications: • Advanced degree in a technical discipline or advanced training in metrology preferred. • Minimum of seven years of “hands-on” facility and/or maintenance management experience with supervisory responsibility. • Energetic and able to function in a rapid-paced and changing environment. • Computer literate and possess ability to use major software tools. • Experience with MRP systems (JDE) preferred. • Prior experience in a manufacturing environment preferred. An Equal Opportunity Employer

Job Features

Job Category

Operations

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...

FullTime
Allen
Posted 2 months 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. Summary: Ability to inspect incoming raw materials pertaining to Disposables and Electronics, in-process and finished products. Act as coordinator within Quality Operations and ensure needs of internal customers are met. Document all non-conformances when necessary. Assist with investigations pertaining to, both, customer complaints and internal non-conformances. Understand, follow, and practice the rules/regulations set forth by the QSR, ISO 13485, and Quest Medical management. General Duties and Responsibilities: • Review processes to assure procedural compliance and recommend improvements. • Provide support during internal, customer and regulatory audits. • Perform and review visual, dimensional and functional inspection of incoming raw materials pertaining to Disposables and Electronics. Ability to identify key inspection points and the proper tools/equipment to ascertain these points. • Perform inspections and verification of finished products. Perform Line clearance and in-process inspections. • Review inspection data and DHRs (including sterilization records) for accuracy and compliance to the applicable standard(s). • Perform inspections and process Returned goods/ materials (RGAs/RMAs). • Evaluate materials for extending Expiration dates. • Use recognized sampling plans to determine statistical size of samples. • Perform and review tests according to various protocol requirements. • Document and review inspection results per GMP/GDP. • Provide/coordinate training for new Technicians. • Generate non-conforming material reports (NCMR) for products that do not conform to test specifications and contact the appropriate personnel. • Communicates needs of department/company to management. • Coordinate needs of internal customers and communicate to technicians in his/her area of responsibility. • Assist engineering staff with process improvement projects regarding improved quality inspection of product and components (such as First Article Inspections and qualification testing) • Evaluate certification status of raw materials under the Supplier Certification program. • Ability to work in Quality Operation areas of IQC, In-process, Finals and Electronics as needed. • Ability to work on projects related to new instrumentation. • Ability to redline documents for improvements or compliance. • Ability to use pallet jack to move materials. • Ability to lift materials weighing up to 50lbs. Qualifications: • High School graduate or equivalent work-related experiences with some previous quality control experience desired (minimum of 5 years). • Strong inspection ability using a caliper, micrometer, vision system including optical comparator, OGP Smart system, and other inspection and measurement tools. • Detail oriented, computer literate and possesses a professional demeanor, be adaptable to changing environments and capable of completing tasks with little or no supervision. Computer skills including MS Office (basic knowledge). • Good written and oral communication skills are required and must be able to read, write, and understand English. Interpersonal skills dealing with other departments/individuals in a team atmosphere important. • Ability to read and interpret engineering DWGs, product specifications, and procedures and use metrology and other testing equipment. Medical device experience desired. Why Join Us: • 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

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...

Allen, Florida
Posted 3 months ago
Quest Medical, Inc. and Halkey Roberts are US based manufacturer’s that develop and manufactures sterile medical devices and components 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, if you are looking for a stable and successful company where your voice will be heard, Quest and Halkey Roberts are the place to be. Position Title: Director of Strategy Reports to: CTO Department: R&D Location: St. Petersburg, FL / Allen, TX Summary: Embark on an exciting career with Quest Medical and Halkey Roberts, where innovation is our heartbeat. As a pioneering force in developing and manufacturing sterile medical devices across diverse medical markets, we're searching for a visionary and creative mind to join our dynamic team. Introducing an opportunity to become our Innovative Director of Strategic Marketing, leading the charge in crafting and defining groundbreaking product initiatives within key business segments such as Cardiovascular, Fluid Management, and Ophthalmology. General Duties and Responsibilities: Market Research: • Conduct thorough market research and analyses for new products in key business segments, staying abreast of competitive offerings. Industry Engagement: • Actively participate in industry conferences to enhance marketing and clinical understanding in key strategic business segments. Collaboration: • Work collaboratively with internal teams (R&D, Clinical, Regulatory, and Marketing) to identify and quantify marketing opportunities and advance effective product strategies. Validation: • Validate new product development concepts through market models, forecasts, and compelling business cases. Opportunity Assessment: • Assess and assist with identification of product opportunities, collecting and analyzing Voice of Customer (VOC) to gauge product need and viability. Strategy Development: • Lead to the development of strategies for new product initiatives in collaboration with customers, Key Opinion Leaders (KOLs), and internal stakeholders. Needs Identification: • Participate in the identification of and collection of customer needs through diverse internal and external sources to ensure our products meet strategic market demands. Product Planning: • Participate in early-phase product planning activities and strategies, providing business justification and formulating effective commercialization strategies. Skills and Qualifications: • Experience: 5+ years of proven experience in product marketing strategy • Education: Bachelor’s degree in Marketing, Business Analytics and Research preferably in medical or a related field. • Skills: Demonstrated expertise in strategic market research and competitive landscape analysis along with market modeling, business development, and product development. • Communication: Excellent communication skills to engage effectively with various stakeholders, including product development teams, superiors, and external collaborators. Notables / Benefits: • Mid-size company with great company culture that is well diverse • Have a voice in the company • 401k with employee matching available • Paid vacation, health/vision/dental, and other excellent benefits An Equal Opportunity Employer

Job Features

Job Category

Marketing

Quest Medical, Inc. and Halkey Roberts are US based manufacturer’s that develop and manufactures sterile medical devices and components for a variety of medical markets. Those markets include cardia...

FullTime
Allen
Posted 3 months 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. Summary: The R&D Engineer I will design and develop new products within the existing product portfolio (Cardiac Surgery, Ophthalmology and IV Therapy) as well as in new markets for Quest Medical. The R&D Engineer I will be responsible for the technical design and engineering of the products and ensure that all requirements are met. The R&D Engineer I will also be expected to participate in ongoing sustaining engineering projects and CAPA projects and provide technical support as required. General Duties and Responsibilities:  Product design activities including 3D modeling and electromechanical system design and prototyping.  Design and develop electromechanical systems to support product development efforts, including automated or semi-automated test and assembly fixturing.  Generate technical drawings, data sheets, and schematics.  Work with senior engineers and Manager to quickly solve technical issues and resolve problems/delays associated with projects.  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.  Select and develop appropriate test tools, applying the latest techniques in testing and verification e.g., data-driven testing and clinical simulations.  Participate in project design reviews with emphasis on gap/risk analysis to ensure projects meet predetermined goals and objectives.  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.  Support collaborative ideation through concept development, prototyping, and feasibility studies.  Assist in the development of customer and product requirements and specifications.  Cultivate understanding of relevant clinical needs, product opportunities, and technology.  Support marketing and clinical assessment of new products and concept initiatives. Help define unmet needs and clinical pathway to address device opportunities.  Participate in the Change Control process to identify the quality implications and impact of proposed changes to product performance via the testing process.  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.  Work with team to address daily issues associated with GMP, safety and enhancing testing infrastructure at Quest. Qualifications:  Bachelor of Science in a technical field such as electrical engineering, mechanical engineering, mechatronics engineering, or other related engineering field is required.  1-3 years of experience in design and development of products. Applicants with an advanced degree in the above fields may be considered with less experience.  >1 year of experience in electromechanical systems design, including design and implementation of systems with off-the-shelf electromechanical components, single-board microcontrollers and computers, custom PCBs, and/or PLC-based systems. Experience with relevant programming languages required.  Skill in mechanical component, part and assembly design and fabrication.  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.  Computer literate and ability to use major software tools including proficiency with CAD programs (SolidWorks preferred).  Knowledge of statistical techniques.  Must demonstrate initiative and require minimal supervision. Self-starter with results driven characteristics.  Ability to communicate effectively.  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.  Project management experience and knowledge of design controls processes and QSR.  Detail oriented and ability to organize large amounts of data. This includes the need for good documentation practices.  General knowledge of good laboratory practices, common laboratory equipment and hazards, upkeep and handling of biologic mediums preferred.  Experience in the medical device industry or in a regulated industry preferred.
Why Join Us: • 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

R&D

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...

FullTime
Allen, TX
Posted 10 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 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. 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.
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.
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...

FullTime
Allen
Posted 1 year 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 10+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be. Summary: The Marketing Manager at Quest Medical, Inc. plays a pivotal role in driving the company's marketing initiatives across its diverse product lines serving cardiac surgery, infusion therapy, and ophthalmology. This position requires an experienced leader with a strategic mindset, capable of managing personnel, collaborating with cross-functional teams, and implementing effective marketing strategies to support sales efforts. General Duties and Responsibilities:
  • Coordinate, organize, and manage all marketing, advertising, and promotional activities in alignment with the Director of Sales and Marketing, ensuring adherence to allocated budgets.
  • Leading projects encompassing trade show planning and logistics, including packing and setup.
  • Drafting Engineering Change Orders, revising product labeling, and updating the company website.
  • Defining strategies to support the product lifecycle effectively.
  • Oversee the creation and management of marketing messaging, collateral, and presentations from ideation to production, ensuring alignment with brand guidelines and strategic objectives.
  • Conduct thorough market analysis through customer and competitive research to identify trends, opportunities, and challenges in target markets.
  • Collaborate with the Director of Sales and Marketing to develop comprehensive marketing plans for new and existing products, ensuring timely implementation and execution.
  • Evaluate the effectiveness of marketing plans and projects through rigorous analytics and reporting, making data-driven recommendations for optimization.
  • Drive the expansion and development of digital marketing platforms, including website analytics/metrics and social media channels, delegating monitoring and reporting tasks as needed.
  • Identify and recommend appropriate mediums to promote Quest Medical, Inc., products, tailoring strategies to target audiences and market segments.
  • Provide tradeshow support including, but not limited to: Application submission, hotel and flight coordination, shipping logistics, set up and dismantle of tradeshow booths, engagement with current and prospective customers.
  • Observe clinical cases in hospitals to gain insights into customer needs and product usage, meeting requirements to enter hospitals via facility credentialing processes.
  • Maintain open communication channels, providing prompt, clear, and concise responses to internal and external stakeholders.
  • Foster strong inter and intra-departmental relationships at Quest Medical, Inc., facilitating collaboration and alignment across teams.
  • Ensure coverage across all Quest product lines, both domestically and internationally, adapting strategies as needed to address regional differences.
  • Monitor industry best practices and evidence-based approaches, exploring opportunities for clinical drivers to enhance marketing effectiveness. Coordinate, organize and manage all marketing, advertising and promotional staff and activities; collaborating with Sales and Marketing Director to appropriately manage budgets.
  Qualifications:
  • Bachelor's degree in Marketing, Business Administration, or related field; advanced degree preferred.
  • Minimum of 5 years of experience in marketing, with a proven record of accomplishment of success in a managerial or supervisory role.
  • Demonstrated expertise in developing and executing marketing strategies, particularly within the medical device or healthcare industry.
  • Strong analytical skills, with the ability to interpret data and draw actionable insights to drive marketing decisions.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
  • Possess the ability to create a compelling PowerPoint presentations and deliver them effectively.
  • Proficiency in digital marketing platforms, including website analytics, SEO, SEM, and social media management.
  • Strategic mindset, with the ability to think creatively and innovatively to solve complex marketing challenges.
  • Proven leadership capabilities, including the ability to motivate and inspire teams to achieve shared goals.
  • Knowledge of regulatory requirements and compliance standards within the medical device industry is desirable.
  • Demonstrate an excellent command of the English language, proficiency in proofreading for grammatical and spelling errors, and be adept at using all Microsoft programs.
  • Valid USiver’s License
Why Join Us:
  • Mid-size company with great company culture that is well diverse
  • Have a voice in the company
  • Average tenure for employee population is 10+ years
  • 401k with employee matching available
  • Paid vacation and other excellent benefits
An Equal Opportunity Employer

Job Features

Job Category

Marketing

Wordpress

1 year

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...