Onsite Senior Supplier Quality Engineer - Medical Devices

Philips; Colorado Springs (CO); On-site; USD 92,000 - 146,000; Full time

Benefits offered by this job

401k match (up to 7%)

HSA with company contribution

Stock purchase plan

Education reimbursement

Generous PTO

Job summary

Philips is seeking a Senior Supplier Quality Engineer to ensure supplier quality and compliance across the Image Guided Therapy Devices business. The role focuses on leading APQP/PPAP, PFMEA, Control Plan, SPC, and audits at the Colorado Springs site, coordinating with QA, Manufacturing, R&D, and suppliers.

Onsite role with strong emphasis on data-driven supplier improvements, cross-functional collaboration, and regulatory alignment to deliver robust product performance and patient safety.

Qualifications

• Minimum 5+ years in Supplier Quality Engineering within FDA-regulated medical device environments.
• Strong experience in PFMEA, SPC, CAPA, APQP/PPAP and supplier audits.
• Knowledge of 21 CFR 803, 806, 820; ISO 13485 and ISO 14971.
• ASQ and/or Six Sigma DfX certifications desirable.

Responsibilities

• Act as the primary SQE contact for the Colorado Springs site, coordinating with QA, Manufacturing, R&D, Sustaining Engineering, Procurement and suppliers.
• Lead MSA, PFMEA, Control Plan, SPC, PV&V, FAI, IQ/OQ/PQ and APQP/PPAP activities to ensure supplier capability and compliance.
• Oversee APQP/PPAP for supplier transfers, changes, SICRs, and sustaining projects.
• Foster Design for Excellence collaboration to improve design quality and manufacturability.
• Lead supplier audits, qualification, and SCAR/CAPA activities.

Skills

PFMEA

SPC

APQP/PPAP

CAPA

SICR

Supplier Audits

Data analytics/KPIs

Education

Bachelor's in Mechanical, Electrical, Biomedical, or Industrial Engineering

Tools

Quality Systems

Job description

Philips is seeking a Senior Supplier Quality Engineer to ensure supplier quality and compliance across the Image Guided Therapy Devices business. The role focuses on leading APQP/PPAP, PFMEA, Control Plan, SPC, and audits at the Colorado Springs site, coordinating with QA, Manufacturing, R&D, and suppliers.

Onsite role with strong emphasis on data-driven supplier improvements, cross-functional collaboration, and regulatory alignment to deliver robust product performance and patient safety.