Supplier Quality Engineer
philips · Colorado Springs
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.
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Published 1 week ago
Expires 1 month from now
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philips
Colorado Springs
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