Supplier Quality Engineer
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Milpitas, CA 95035
Description:
Roles & Responsibilities:
- ISO 13485, Supplier Quality, NC/CAPA, Purchasing Control, 21 CFR 820, Part or Component Qualification, Equipment Verification & Validation activities.
- 10 + years of proven experience required (including 4+ years of medical devices domain & Supplier management experience preferred).
- Experience with relevant Supplier Quality requirements is required.
- Management of complete supplier Quality lifecycle.
- Supplier Audit.
- Part / Component Qualification.
- Verification of Verification & Validation activities (hands on experience on IQ/OQ/PQ activities required).
- Review & approval of supplier Documentations.
- Supplier Site visits as and when required.
- Supplier NC/CAPA lifecycle Management.
- Weekly/Monthly Project progress dashboard generations.
- Supplier related Riska Management.