Quality Engineer
Salary undisclosed
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Title: Quality Engineer
Location: Milpitas, CA
ISO 13485, Supplier Quality, NC/CAPA, Purchasing Control, 21 CFR 820, Part or Component Qualification, Equipment Verification & Validation activities
Essential Skills:
- Knowledge of Supplier Quality Related activities
- Exposure to ISO 13485 / 21 CFR 820 / Purchasing Control
- Equipment Verification/ Validation
- Part/Component Qualification
Supplier Audit
Desirable Skills:
- 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 Risk Management
Title: Quality Engineer
Location: Milpitas, CA
ISO 13485, Supplier Quality, NC/CAPA, Purchasing Control, 21 CFR 820, Part or Component Qualification, Equipment Verification & Validation activities
Essential Skills:
- Knowledge of Supplier Quality Related activities
- Exposure to ISO 13485 / 21 CFR 820 / Purchasing Control
- Equipment Verification/ Validation
- Part/Component Qualification
Supplier Audit
Desirable Skills:
- 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 Risk Management