Senior Supplier Quality Engineer

Philips•Colorado Springs, CO

7h•Onsite

About The Position

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.

Requirements

Minimum of 5+ years' experience in Supplier Quality Engineering within FDA regulated medical device (Class II & III) manufacturing/supplier environments.
Strong experience in supplier selection, performance assessment, Risk Assessments/PFMEA’s, SPC, SCAR’s, SICR, CAPA, and related APQP/PPAP activities.
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).
Proven experience utilizing data analytics/KPI’s to assess supplier performance and identify/drive process improvement opportunities.
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.
Bachelors Degree in Mechanical, Electrical, Biomedical, or Industrial Engineering, or related technical discipline.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
For this position, you must reside in or within commuting distance to Colorado Springs, CO.

Nice To Haves

ASQ and/or Six Sigma DfX Certifications

Responsibilities

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.