Senior Supplier Quality Engineer – Medical Devices

About the role

The Senior Supplier Quality Engineer ensures supplier quality, compliance, and process capability across sustaining activities within Philips’ Image Guided Therapy Devices business. Serves as the primary Supplier Quality Engineering point of contact for the Colorado Springs facility, providing on‑site support and aligning with Quality, Manufacturing, R&D, Sustaining Engineering, Procurement, and suppliers.

Key responsibilities

• Lead and own MSA, PFMEA, Control Plan, SPC, PV&V, FAI, IQ/OQ/PQ, and related APQP/PPAP activities to ensure supplier process capability and compliance.
• Execute APQP/PPAP for supplier transfers, changes, SICRs, and sustaining projects supporting the Fremont, CA manufacturing facility.
• Facilitate Design for Excellence collaboration between R&D, Sustaining Engineering, Manufacturing, and suppliers to improve design quality and manufacturability.
• Define and flow down Critical to Quality characteristics to suppliers, validate through controls, and maintain throughout production.
• Lead supplier audits (initial qualification, for‑cause, follow‑up) to assess compliance with quality system requirements and regulatory expectations.
• Manage supplier qualification for addition to the Approved Supplier List, including capability assessment and risk classification.
• Investigate supplier‑related non‑conformances, conduct root‑cause analysis, and coordinate corrective actions.
• Drive systemic supplier improvement using performance data, NC trends, audit outcomes, and process capability indicators.

Required profile

• Minimum 5+ years experience in Supplier Quality Engineering within FDA‑regulated medical device (Class II & III) manufacturing.
• Bachelor’s degree in Mechanical, Electrical, Biomedical, or Industrial Engineering (or related technical discipline).
• ASQ and/or Six Sigma DfX certifications are desired.

Required skills

• MSA, PFMEA, Control Plan, SPC, PV&V, FAI, IQ/OQ/PQ.
• APQP, PPAP, Supplier Audits, SCAR, CAPA.
• Data analytics and KPI analysis for supplier performance.
• Knowledge of FDA 21 CFR Parts 803, 806, 820.
• Familiarity with ISO 13485, ISO 14971, EU MDR.
• Risk assessment and mitigation techniques.

What we offer

• Base salary range $92,000 – $146,000 per year.
• Annual incentive bonus and long‑term incentives.
• Comprehensive benefits including generous PTO, 401(k) with up to 7% match, HSA contributions, stock purchase plan, and education reimbursement.
• Opportunity to work on cutting‑edge medical imaging devices that improve patient outcomes.