CooperSurgical · 18 hours ago
Supplier Quality Engineer II
Trumbull, CT
Full-time
Onsite
Mid Level
3+ years expCooperSurgical is a leading fertility and women’s healthcare company dedicated to enhancing the healthcare experiences of women and families. The Supplier Quality Engineer II will support the Global Supplier Quality Program, ensuring compliance with regulatory requirements and corporate standards, while managing supplier quality activities and collaborating with various teams.
Health CareMedical DeviceWomen's
Responsibilities
Manage Supplier Quality sustaining activities
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, Engineering and Quality Engineering; confirm there is a Supplier related improvement opportunity or Non-Conforming Material Reports (NCMRs)
Support development & implementation of supplier quality program by:
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
Support internal and external QMS audits, and work as a key player in the audit’s backup 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
When required, submit Supplier Corrective Action Requests (SCAR) for Supplier related NCMRs, and review Supplier responses for appropriate root-cause analysis and Corrective Actions to prevent reoccurrence 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 other duties as assigned
Qualification
Required
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
Previous experience negotiating with Suppliers
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
Computer skills, MS Office, Minitab, and previous experience with ERP and QMS systems
Understanding, knowledge and application of relevant processes and the various cost drivers per market, commodity or segment
3+ years in regulated quality environment
3+ years in working with Supplier Management processes
Bachelor's Degree in Chemical, Electro-Mechanical, Industrial, Bioprocess Engineering or related to Life Science field or equivalent experience or skillset
Preferred
CQE, APICS, Green Belt or Black Belt certifications are a plus
Benefits
Medical coverage
401(k)
Parental leave
Fertility benefits
Paid time off for vacation
Personal
Sick and holidays
Multiple other perks and benefits
Company
CooperSurgical
CooperSurgical provides a full portfolio of medical and surgical products. It is a sub-organization of The Cooper Companies.
1001-5000 employees
H1B Sponsorship
CooperSurgical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (10)
2023 (10)
2022 (13)
2021 (5)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Lisa Fawcett
Executive Vice President, Strategy & Market Development
Recent News
MarketScreener
2025-08-29
2025-08-27
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