Quality Assurance Specialist
2 weeks ago
CooperSurgical is a leading provider of innovative solutions for women's healthcare and fertility. Our mission is to empower women, babies, and families by delivering high-quality products and services that meet the evolving needs of the healthcare industry.
Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for managing supplier quality sustaining activities, facilitating supplier compliance programs, and ensuring that our suppliers meet the highest standards of quality and regulatory compliance.
Key Responsibilities- Manage Supplier Quality sustaining activities, including supplier compliance programs, site audits, and supplier development.
- Act as a quality assurance consultant to develop and implement quality systems in compliance with FDA QSR, ISO 13485, and other relevant requirements at partner suppliers/vendors.
- Support the development and implementation of supplier quality programs, including supplier on-going monitoring and re-evaluation, supplier quality agreements, and supplier-related metrics/reporting.
- Support internal and external QMS audits, and work as a key player in the audit's backup rooms or inspection rooms.
- File and maintain 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.
- Collaborate with Quality Engineers, Inspectors, Value Streams, and Purchasing teams.
- Submit Supplier Corrective Action Requests (SCAR) for Supplier-related NCMRs and 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.
- 3-7 years of experience in a regulated quality environment.
- Knowledge of FDA QSR, ISO 13485, EUMDR, and ISO 14971.
- Previous experience in supply chain, auditing, verification, and validation.
- Excellent verbal and written communication skills and strong organizational skills.
- University bachelor's degree in Chemical, Electro-Mechanical, Industrial, Bioprocess Engineering, or related to Life Science field or equivalent experience or skill sets.
- CQE, APICS, Green Belt, or Black Belt certifications are a plus.
- Advance level of English speaking and writing.
- Traveling experience is a plus.
As an employee of CooperSurgical, you'll receive an outstanding total compensation plan, including 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 www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.
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