Principal Quality Assurance Engineer
3 days ago
CooperSurgical is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals.
We are seeking a highly skilled Principal Quality Assurance Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest level of quality in our products and services.
Responsibilities- Lead and determine correct PPAP levels with the ability to write protocols of IQ, OQ, PQ, and PPAP checklists and warrants.
- Full knowledge, application, and management of Supplier Quality sustaining and strategic activities.
- Knowledge and full understanding of medical device requirements (e.g., FDA QSR, ISO 13485, EU MDR, CMDCAS).
- Support transfer projects and Supplier localization projects.
- Facilitate the supplier compliance program (site audit, drive improvement in supplier performance, supplier development, supplier selection, and qualification).
- Act as a quality assurance consultant in the development and implementation of quality systems in compliance with FDA QSR, ISO 13485, MDD, and CMDCAS and other relevant requirements at partner suppliers/vendors.
- Work with Value Streams to confirm there is a Supplier-related improvement opportunity or Non-Conforming Material Reports (NCMRs).
- Support the development and implementation of supplier quality programs.
- Support internal and external QMS audits.
- Perform supplier audits and conduct supplier site visits as needed to identify systemic gaps in performance expectations at suppliers.
- Work collaboratively with Quality Engineers, Inspectors, Value Streams, and Purchasing, Engineering teams.
- Bachelor's degree or Master's degree.
- Black Belt a plus.
- Certified Quality Engineer, Certified Reliability Engineer a plus.
- Minimum 7 to 10 years of related experience in PPAP and IQ, OQ, PQ validations.
- 5 to 7 years in regulated quality environments.
- Evaluate and provide input into Risk Management processes both internal and external.
- Working knowledge of Lean Principles, Six Sigma, and their application.
- Perform and drive Supplier Development activities and improvements.
- With previous experience negotiating with Suppliers.
- Certified Quality Engineer, Black Belt, or equivalent certifications.
- Master's degree or equivalent work experiences.
We offer a competitive compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick, and holidays, and multiple other perks and benefits.
Please visit https://www.coopersurgical.com/careers to learn more about CooperSurgical and the benefits of becoming a member of our team.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status.
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