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Supplier Quality Engineer

philips · Colorado Springs

Onsite Junior 63,000 - 100,000 USD/year 🇬🇧 English
MSA PFMEA SPC FAI APQP PPAP SICR SCAR CAPA IQ/OQ/PQ data analytics risk assessment ISO 13485 ISO 14971

Job description

About the role

The Supplier Quality Engineer supports supplier qualification, audits, and onboarding within Philips' Image Guided Therapies – Devices business. The role drives APQP/PPAP execution, process validation, and continuous improvement initiatives for our medical device suppliers.

Key responsibilities

  • Execute MSA, PFMEA, Control Plans, SPC, PV&V, and FAI as part of APQP/PPAP activities.
  • Conduct supplier audits, qualify new suppliers for the Approved Supplier List, and manage supplier‑initiated change requests (SICR).
  • Investigate supplier non‑conformances, coordinate SCARs, and ensure effective corrective actions.
  • Support supplier development and improvement programs, providing guidance on quality processes and regulatory compliance.

Required profile

  • Minimum 1 + year experience in Supplier Quality or Quality Engineering in a regulated environment (medical devices preferred).
  • Knowledge of medical device regulations and standards (21 CFR 803/806/820, ISO 13485, ISO 14971, EU MDR, etc.).
  • Associate’s degree required; Bachelor’s degree and/or ASQ/Six Sigma certifications are a plus.

Required skills

  • Measurement System Analysis (MSA)
  • Process Failure Mode and Effects Analysis (PFMEA)
  • Statistical Process Control (SPC)
  • Process Validation & Verification (PV&V)
  • First Article Inspection (FAI)
  • Advanced Product Quality Planning (APQP) and Production Part Approval Process (PPAP)
  • Supplier Initiated Change Request (SICR) and Supplier Corrective Action Request (SCAR)
  • Data analytics and KPI‑driven supplier performance assessment
  • Risk assessment and CAPA implementation

What we offer

  • Competitive salary range $63,000 – $100,000 per year.
  • Comprehensive total‑rewards package including PTO, 401(k) match up to 7 %, HSA contributions, stock purchase plan, and education reimbursement.

Questions fréquentes

Le salaire proposé pour ce poste est de 63-100k 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

Colorado Springs