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Supplier Quality Engineer – Medical Devices

philips · Bedford

Senior 103,000 - 163,000 USD/year 🇬🇧 English
APQP PFMEA SPC SCAR CAPA Data analytics KPI Six Sigma

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.

Questions fréquentes

Le salaire proposé pour ce poste est de 103-163k USD par an. Le détail figure dans l'annonce.
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Source : ats:workday

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Published 1 week ago

Expires 1 month from now

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philips

Bedford