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Supplier Quality Engineer
Katalyst Healthcares & Life Sciences
🇨🇦 Canada | 🇺🇸 United States
On-site
2 months ago
- PFMEA
- Risk Management
2 months ago
Not enough detail in this posting to match
Supplier Quality Engineer is responsible for ensuring suppliers deliver quality materials, components, and services in compliance with regulatory and organizational requirements within the medical device industry.
Roles & Responsibilities:
- Ensure suppliers consistently deliver quality parts, materials, and services meeting Healthcare requirements.
- Evaluate and onboard new suppliers into the Approved Supplier List (ASL).
- Perform product and feature-level quality impact assessments and maintain necessary documentation.
- Review and approve PPAP documentation including Control Plans, Process Flow Charts, Process Drawings, Capability Studies, DFMEA, and PFMEA.
- Conduct supplier risk segmentation and maintain risk profiles.
- Facilitate Supplier Quality Agreements and conduct supplier audits.
- Coordinate supplier evaluation and selection activities for new suppliers or changes to existing products/processes.
- Support and approve Process Validation activities (IQ, OQ, PQ), MSA/TMV, and Control Plans.
- Route documentation in PLM systems and follow up for approvals and release.
- Collaborate with Global Supplier Quality teams to implement Supplier Data Review (SDR) / Supplier Owned Quality (SOQ) activities.
- Bachelor's degree in engineering, Technical, or Scientific discipline.
- Minimum 8 years of experience in Supplier Quality or related roles within the Medical Device industry.
- Strong knowledge of regulatory standards, quality systems, and supplier quality processes.
- Experience with PPAP, risk management, process validation, and quality tools (DFMEA, PFMEA, MSA).
Supplier Quality Engineer · Katalyst Healthcares & Life Sciences