Senior Supplier Quality Engineer, External Manufacturing

CooperSurgical

Livingston (NJ)

Hybrid

USD 100,000 - 125,000

Full time

5 days ago

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Benefits offered by this job

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off

Job summary

CooperSurgical’s Senior Supplier Quality Engineer (External Manufacturing) ensures quality oversight of external manufacturing and supplier performance. You will drive CAPA, PPAP/FAI, and regulatory compliance across contract manufacturers, interfacing with suppliers and CooperSurgical teams.

Responsibilities include leading quality reviews, data trend analysis, and risk-based improvements. This role emphasizes cross‑functional collaboration, supplier qualification, and continuous quality

Qualifications

5+ years in supplier quality, external manufacturing, or process engineering.
7+ years in a regulated quality environment (medical device, pharma, life sciences).
Experience with global suppliers and contract manufacturers preferred.

Responsibilities

Oversee external manufacturing suppliers for development and execution of plans and systems.
Lead routine quality reviews with external manufacturing partners to ensure compliance.
Provide day-to-day quality oversight of contract manufacturing operations.
Review and trend quality data from external sites and implement CAPA.
Approve suppliers based on risk, performance, and business needs.
Lead PPAP/FAI reviews for new products or components.
Investigate supplier-related issues and drive quality engineering methodologies.
Support audits and maintain supplier quality documentation.
Participate in MRB activities and containment decisions.
Ensure process validation protocols IQ/OQ/PQ and change control processes.