What are the responsibilities and job description for the Medical Device Engineer (Supplier Quality Engineer) position at Katalyst CRO?
Roles & Responsibilities
- ISO 13485, Supplier Quality, NC/CAPA, Purchasing Control, 21 CFR 820, Part or Component Qualification, Equipment Verification & Validation activities.
- Knowledge of Supplier Quality Related activities.
- Exposure to ISO 13485 / 21 CFR 820 / Purchasing Control.
- Equipment Verification/ Validation.
- Part/Component Qualification.
- Supplier Audit.
- 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 Risk Management.
