Job Summary
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The Lead Design Quality Engineer will provide Design Quality Engineering support and leadership to ensure the successful development of Cooper products and ongoing operational support.This individual will be expected to apply his/her knowledge of design control principles and quality engineering techniques to positively influence development efforts as needed.In parallel, this person shall also ensure the products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.Review and evaluate scientific and technical data as it pertains to product and product testing and lead teams to identify and solve complex product problems. This position also coaches, reviews and delegates work to lower level specialists.
1. Quality RepresentationActively represent Quality function on product/process development teams.Mentor other discipline as needed in the Quality Engineering methodology.Provide guidance to Engineering staff and other personnel and ensures that design control requirements are being met in an effective manner, including those for design verification, validation, specification and procedure development, risk management, and design review.
2. Supplier EngagementManage supplier new tooling to ensure final components are qualified at the supplier and on time utilizing PPAP tool. Participates in supplier selection process and specification reviews with suppliers to ensure that purchased items meet Cooper’s specifications.Specifies quality characteristics and inspection plans for components, subassemblies, and finished devices with the Engineering Team.
3. CAPAs/Non conformancesLead or Participate in the investigation of complex product problems. Identify and manage corrective actions resulting from problem investigations.Evaluates and dispositions nonconforming materials and products used in pilot and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements.
4. Design Participate in design reviews to evaluate designs and to help identify alternative design solutions.Hands on participant in early stages of product development including but not limited to physician interaction, product engineering, competitive product testing, and prototype testing.Provides input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and testedContributes to design input requirements from experience with previously reported problems, Cooper’s products, competitive devices and/or other similar products.
5. V&VParticipate in the development of the master test plans (. trace matrix, VMP….) that encompass design verification, design validation and process validation activities.Creation, evaluation, and validation of product and process test methods.Evaluates test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.
6. RiskIdentifies and manages risk throughout the development process with the use of FMEAs and/or other risk management tools. This includes leading the Risk management efforts of the design process and working with design team and management team on managing product and process risks.
7. Process ImprovementActively identifies and leads opportunities for improvements across all cross functional departments. Promotes continuous improvement in design control activities and use of quality tools with design team and other departments.
8. RegulatoryComply with applicable FDA and international regulatory laws/standards and the Cooper’s Code of Conduct.Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices.Represent Cooper as needed in FDA, notified body, internal, and other audits.
9. Thorough knowledge of statistics and how to apply, evaluate, and provide recommendation from the data.
10. Perform other duties as assigned.
Travel: This position may require 5-10% domestic and/or international travel.
Knowledge, Skills and Abilities:
11. Knowledge of applicable laws and regulations.
12. Intermediate skill in the use of Excel, Word and PowerPoint. Advanced preferred.
13. Ability to read and understand highly technical material.
14. Proficient in reading and writing in English
15. Self-motivated and committed to a team approach
16. Strong interpersonal, organizational and project management skills
17. Strong oral, presentation and technical writing skills
18. Demonstrated skills in decision making preferably across a broad spectrum of Quality Engineering responsibilities
19. Proven experience leading cross-functional teams in a medical device development environment.
20. Strong analytical and problem-solving skills with acute attention to detail.
21. Excellent communication and interpersonal skills.
Work Environment:
22. Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.
23. Occasionally lift to 35 pounds.
Experience:
24. 7+ years experience in Quality Engineering in the medical device industry. Experience in related engineering areas,. R&D; or Manufacturing may also be applicable if experience includes work responsibilities listed above.
25. Experience in medical devices, with knowledge in women’s health is preferred.
Education:
26. Bachelor’s Degree or higher in Science or Engineering (or related field)
27. Certification in Quality Engineering (ASQ Certified Quality Engineer)