Principal Quality Assurance Engineer

2 weeks ago

Trumbull, Connecticut, United States Cooper Companies Full time
Job Title: Principal Quality Assurance Engineer

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.

Responsibilities:
  • Lead and determine correct PPAP levels with the ability to write protocols of IQ, OQ, PQ and PPAP checklist and warrants.
  • Full knowledge, application and management of Supplier Quality sustaining and strategic activities.
  • Knowledge and full understanding of the medical device requirements (e.g., FDA QSR, ISO 13485, EU MDR, CMDCAS and etc..).
  • 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 in order to support operations and development engineering.
  • Work with Value Streams once Engineering and Quality Engineering; confirm there is a Supplier related improvement opportunity or Non-Conforming Material Reports (NCMRs).
  • Support development and implementation of supplier quality program by doing the following:
  • a. Support supplier on-going monitoring and re-evaluation process.
  • b. Manage Supplier SCAR / CAPA / NCR and periodically provide metrics/report to Management Review Process.
  • c. Create/Maintain supplier quality agreements.
  • d. Support all Procurement supplier Projects.
  • e. Support all new Product Development that is intended for production at suppliers.
  • f. Support all business continuity projects at suppliers.
  • g. Update SOPs and Forms related to supplier management process as needed
  • Supports internal and external QMS audits. And works as a key player in the audit's backup rooms or inspection rooms.
  • Files and maintains Supplier related documentation as per QMS.
  • Perform supplier audits, conduct supplier site visits as needed to identify systemic gaps in performance expectations at suppliers and implement mitigating processes at Cooper sites, as needed.
  • Works and leads collaborative activities with Quality Engineers, Inspectors, Value Streams as well as Purchasing, Engineering teams.
  • When required, submits Supplier Corrective Action Requests (SCAR) for Supplier related NCMRs. And reviews Supplier responses for appropriate root cause analysis and Corrective Actions to prevent re-occurrence of failure modes.
  • Performs additional assignments as required by management.
  • Create a critical review of supplier strategies and segmentation strategies.
Qualifications:
  • Bachelor's degree / 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 environment.
  • 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
  • Execution and driver of results as a team lead and as an active participant
  • Serves as a leader and a coach in in Supplier Management, Quality Tools, analytic evaluations, risk management, Dfx, and other engineering activities.
  • Able to define, implement and manage a nonconformance system.
  • Fully understand 8-D process and have the ability.
  • Full understanding and application of FDA QSR, ISO 13485, and other applicable regulations
  • Working knowledge of Dfx, Risk Management, and Data Analysis
  • Working knowledge and ability to properly problem solve utilizing the appropriate Quality Tools
  • Effectively evaluate drawings and provide improvements and recommendations if necessary (e.g., dimensions, tolerances, notes, and etc.)
  • Understanding, knowledge and application of relevant processes and the various cost drivers per market, commodity or segment.
  • Previous experience in supply chain, auditing, verification, and validation, GD&T.
  • Previous experience with Change Control Systems and Design Control.
  • Excellent verbal and written communication skills and strong organizational skills
  • Advance level of English speaking and writing. Traveling experience is a plus.
  • Computer skills, MS Office, Minitab, and previous experience with ERP and QMS systems.
  • Passing of background check, which may include verification of prior employment, criminal conviction history, education and driving records.

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great 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 us at 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. We are proud to be an equal opportunity workplace.

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