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Senior Supplier Quality Engineer – External Manufacturing
CooperCompanies. Oversee external manufacturing suppliers and implement supplier qualification, monitoring, and disengagement controls .
Tech Stack
Tools & technologiesAssembly
About the role
Key responsibilities & impact- Oversee external manufacturing suppliers and implement supplier qualification, monitoring, and disengagement controls
- Lead operational quality reviews with external manufacturing partners
- Provide day-to-day quality oversight of contract manufacturing, including batch record review, production monitoring, nonconformance management, and quality issue escalation
- Review and trend deviations, scrap, yield, complaints, rework, and CAPA effectiveness
- Approve suppliers based on risk, performance history, and business alignment
- Lead PPAP/FAI reviews and qualification of new products or components
- Investigate and resolve supplier-related challenges using Quality Engineering methodologies
- Support purchasing control audits and maintain supplier quality documentation, audit reports, and qualification packages
- Participate in MRB activities and support containment, rework, disposition, and defect prevention
- Review and approve IQ/OQ/PQ process validation protocols
- Ensure adherence to control plans, PFMEA, SOPs, industry regulations, and organizational policies
- Support engineering changes, product transfers, tooling validation, ramp-ups, NPI products, quality reviews, audits, deviations, CAPAs, and product disposition
- Perform on-site quality oversight visits at contract manufacturing facilities
- Monitor OPEX and supplier performance metrics, including PPM, defect trends, NCRs, OEE, delivery, complaint rates, and SCAR closure effectiveness
- Provide updates and reports to supply chain leadership
- Lead supplier business reviews and develop supplier improvement plans
- Manage supplier scorecards and continuous improvement expectations
- Liaise between suppliers and the CooperSurgical team
- Communicate with third-party manufacturers regarding forecasts, manufacturing, and delivery schedules
- Ensure adherence to Supply Agreement and Quality Agreement terms
Requirements
What you’ll need- Strong understanding of manufacturing processes, including injection molding, machining, assembly, packaging, electronics, and finished good manufacturing
- Proficiency with APQP, PPAP, FMEA, SPC, MSA, and AQL
- Ability to analyze data and interpret statistical trends
- Experience with global manufacturing and supplier management
- Familiarity with international regulatory requirements and market trends
- Strong communication and negotiation with external suppliers
- Ability to influence without authority
- Cross-functional leadership and project management skills
- 5+ years in supplier quality, external manufacturing, process engineering, or relevant experience
- 7+ years in a regulated quality environment such as medical device, pharma, or life sciences
- Experience with global suppliers and contract manufacturers preferred
- Bachelor’s degree in engineering or equivalent experience or skillset
- Ability to work in manufacturing, clean room, warehouse, and office environments
- May require extended periods of sitting, standing, and movement in production and supplier facilities
- Up to 30% domestic and/or international travel may be required
Benefits
Comp & perks- Medical coverage
- 401(k)
- Parental leave
- Fertility benefits
- Paid time off for vacation, personal, sick, and holidays
- Multiple other perks and benefits
- Potential eligibility for other types of compensation