Supplier Quality Engineer/Assurance

CooperVision-posted 3 months ago
Full-time • Mid Level
Trumbull, CT
Miscellaneous Manufacturing
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CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Work location: Trumbull, CT (on-site). Under the direction of the Manager, Supplier Quality, this position is responsible to support all functions of Global Supplier Quality Program are consistently in compliance with regulatory requirements and corporate standards. Ensures that quality standards are met by all suppliers to CooperSurgical.

  • Manage Supplier Quality sustaining activities.
  • Facilitates the supplier compliance program (Site audit, drive improvement in supplier performance, supplier development, supplier selection and qualification).
  • Acts 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.
  • Works with Value Streams once Engineering and Quality Engineering; confirm there is a Supplier related improvement opportunity or Non-Conforming Material Reports (NCMRs).
  • Support supplier on-going monitoring and re-evaluation process.
  • Manage Supplier SCAR / CAPA / NCR and periodically provide metrics/report to Management Review Process.
  • Create/ Maintain supplier quality agreements.
  • Support all Procurement supplier Projects.
  • Support all new Product Development that is intended for production at suppliers.
  • Support all business continuity projects at suppliers.
  • Update SOPs and Forms related to supplier management process as needed.
  • Supports internal and external QMS audits.
  • Perform supplier audits, conduct supplier site visits as needed to identify systemic gaps in performance expectations at suppliers.
  • Collaborates with Quality Engineers, Inspectors, Value Streams as well as Purchasing teams.
  • Submit Supplier Corrective Action Requests (SCAR) for Supplier related NCMRs.
  • Review Supplier responses for appropriate root cause analysis and Corrective Actions to prevent re-occurrence of failure modes.
  • Support supplier validation activities as required from Supplier Quality prospective.
  • Support transfer projects and Supplier localization projects.
  • Support IQ, OQ, PQ and PPAP processes.
  • Perform additional assignments as required by management.
  • Knowledge of FDA QSR, ISO 13485, EUMDR, ISO 14971.
  • Knowledge and experience with a regulated Supplier Management process.
  • Previous experience in supply chain, auditing, verification, and validation.
  • Previous experience with Change Control Systems, FDA QSRs and ISO 13485.
  • Excellent verbal and written communication skills and strong organizational skills.
  • Bachelor's Degree in Chemical, Electro-Mechanical, Industrial, Bioprocess Engineering or related to Life Science field or equivalent experience or skill sets.
  • 5 or more years of related experience in a regulated quality environment.
  • Advance level of English speaking and writing.
  • Computer skills, MS Office, Minitab, and previous experience with ERP and QMS systems.
  • CQE, APICS, Green Belt or Black Belt certifications are a plus.
  • Traveling experience is a plus.
  • Experience negotiating with Suppliers.
  • Outstanding total compensation plan.
  • Medical coverage.
  • 401(k).
  • Parental leave.
  • Fertility benefits.
  • Paid time off for vacation, personal, sick and holidays.
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