Senior Supplier Quality Engineer

Senior Supplier Quality Engineer

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, CO facility, providing on-site support ensuring timely alignment with site Quality, Manufacturing, R&D, Sustaining Engineering, Procurement, and supplier stakeholders.
• Leads and owns MSA, PFMEA, Control Plan, SPC, PV&V, FAI, IQ/OQ/PQ, and related APQP / PPAP activities to ensure supplier process capability, validation readiness, and compliance with quality requirements.
• Leads APQP / PPAP execution for supplier transfers, supplier changes, SICRs, and sustaining projects supporting the Fremont, CA manufacturing facility.
• Facilitates Design for Excellence collaboration between R&D, Sustaining Engineering, Manufacturing, and suppliers to improve design quality, manufacturability, supplier process robustness, and long-term product performance.
• Ensures Critical to Quality characteristics are clearly defined, flowed down to suppliers, validated through appropriate controls, and maintained throughout production.
• Leads supplier audits, including initial qualification, for-cause, and follow-up audits, to assess supplier compliance with applicable quality system requirements, regulatory expectations, process controls, and supplier agreement obligations.
• Leads supplier qualification activities for addition to the Approved Supplier List, including supplier capability assessment, quality system maturity evaluation, technical readiness, risk classification, approval documentation, and onboarding completion.
• Leads supplier-related non-conformance investigations, including defect analysis, supplier-cause determination, containment, risk assessment, escalation, and disposition support.
• Initiates, coordinates, and manages Supplier Corrective Action Requests, ensuring effective root cause analysis, corrective/preventive action implementation, verification of effectiveness, and timely closure.
• Drives systemic supplier improvement using supplier performance data, NC trends, audit outcomes, SCAR history, defect recurrence, and process capability indicators.

• You have a minimum of 5+ years' experience in Supplier Quality Engineering within FDA regulated medical device (Class II & III) manufacturing/supplier environments.

• You have strong experience in supplier selection, performance assessment, Risk Assessments/PFMEA’s, SPC, SCAR’s, SICR, CAPA, and related APQP/PPAP activities.

• You have detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282).
• You have proven experience utilizing data analytics/KPI’s to assess supplier performance and identify/drive process improvement opportunities.
• You have strong communications skills and the proven ability to effectively influence and build relationships cross-functionally with a variety of internal/external stakeholders, suppliers, Regulatory Agencies, Notified Bodies etc.
• You have a Bachelors Degree in Mechanical, Electrical, Biomedical, or Industrial Engineering, or related technical discipline. ASQ and/or Six Sigma DfX Certifications
  - Desired.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position
  .

We believe that we are better together than a part. For our Office-based teams, this…