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: The Vice President of Operations is a key member of the Company’s Senior Leadership team.  This position is responsible for overseeing and optimizing the company’s operational functions to ensue efficient production, quality, and distribution of medical devices.  This role requires a combination of strategic thinking, leadership, and hands-on management to drive excellence in operations.   Requirements:

• Bachelor of Science in a relevant field (e.g. Engineering or Operations Management). MBA or MS in relevant discipline preferred.
• 15+ years of proven leadership experience in role of progressive responsibility within the medical device industry or related fields.
• Excellent working knowledge of the FDA Quality System Regulations, EU Medical Device Regulations, ISO 13485, and ISO 14971.
• Excellent leadership, interpersonal, and negotiation skills.
• Demonstrated ability to drive change and lead continuous improvement initiatives that enhance performance and scalability.
• Significant experience with computerized manufacturing management systems, methods, and an in-depth knowledge of computer-based ERP systems, controls, and capabilities.
• Demonstrated leadership utilizing process improvement strategies such as Lean, Six Sigma, or other TQM processes.
• Strong financial acumen

    Responsibilities:

• Collaborate with the executive team to set the strategic direction of the company. Develop and execute operational strategies to support and grow productivity, quality, and fiscal corporate objectives.
• Implement best practices to optimize efficiency and reduce cost. Mitigate risks and develop contingency plans.
• Drive innovation in manufacturing methods to improve product quality and production efficiency. Collaborate with engineering staff to develop capital expenditure strategies which improve efficiencies, foster cost savings, and enhance revenue.
• Champion continuous improvement of business systems and processes to enhance efficiency and scalability.
• Build and lead an operations team, providing mentorship, coaching, team-building, and performance management. Foster a culture of collaboration, accountability, and continuous improvement for a high-performance, results-oriented work culture.
• Develop departmental budgets and allocate resource effectively. Drive initiatives to improve operational profitability and reduce waste.
• Establish and utilize key performance indicators in the areas of safety, quality, delivery, cost, capacity, and staff productivity. Use data-driven insights to inform strategic decisions and drive operational excellence.
• Ensure compliance with health and safety regulations, creating a safe working environment for all employees.
• Maintain rigorous standards in compliance with relevant regulatory requirements (e.g. FDA, EU, ISO).
• Oversee the supply chain, including production planning, procurement, inventory management, and supplier relationships. Utilize ERP, PLM, and MES tools to optimize capacity planning, material movement, manufacturing floor management, and reporting.
• 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.
• Optimize warehousing operations to ensure on-time delivery of products to customers.
• Oversee maintenance activities to ensure equipment reliability and facility compliance. Plan for facility expansion or improvement projects to support company growth.

  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  

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

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    

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