Supplier Quality Engineer – Medical Devices
philips · Bedford
Job description
About the role
The Supplier Quality Engineer is a key member of Philips’ Image Guided Therapy Devices (IGTD) Quality team, responsible for driving supplier performance, continuous improvement, and regulatory compliance throughout the product lifecycle.
Key responsibilities
- Coordinate and execute supplier improvement initiatives, manage the Approved Supplier List and negotiate Supplier Quality Agreements.
- Provide sustaining SQE activities, handling daily NCRs, SCARs, SCNs, and APQP with selected suppliers.
- Facilitate technical capability assessments of new suppliers and support supplier selection.
- Monitor product and process quality trends, troubleshoot production/release issues, and lead continuous‑improvement projects.
- Develop equipment qualification and process validation plans, and oversee product/process change requests from suppliers.
- Act as internal and supplier quality auditor, managing audit planning, execution, reporting and closure.
Required profile
- Minimum 5 + years experience in Supplier Quality Engineering within FDA‑regulated medical device environments.
- Strong knowledge of medical device regulations (21 CFR Parts 803, 806, 820, ISO 13485, ISO 14971, EU MDR, etc.).
- Proven ability to use data analytics and KPIs to assess supplier performance and drive improvements.
- Bachelor’s degree in Quality, Engineering or related field; ASQ and/or Six Sigma certification preferred.
Required skills
- APQP
- PFMEA
- Statistical Process Control (SPC)
- Supplier Corrective Action Requests (SCAR)
- CAPA management
- Data analytics and KPI reporting
- Risk assessment
- Six Sigma methodology
What we offer
- Base salary range $103,000 – $163,000 per year.
- Annual incentive bonus and long‑term incentive opportunities.
- Comprehensive benefits including generous PTO, 401(k) match up to 7 %, HSA contributions, stock purchase plan and education reimbursement.
- Opportunity to work on cutting‑edge health‑technology products in a collaborative environment.
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Published 1 week ago
Expires 1 month from now
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philips
Bedford
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