Senior Supplier Quality Engineer - Medical Devices, Onsite

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

Job summary

Philips in Colorado Springs is seeking a Senior Supplier Quality Engineer to own supplier quality, compliance, and process capability across sustaining activities for the Image Guided Therapy Devices portfolio.

You will lead APQP/PPAP, PFMEA, SPC, SCAR/CAPA, supplier audits and qualification, coordinating with R&D, Manufacturing and suppliers to ensure robust designs, qualification readiness, and ongoing quality improvements.

Qualifications

• Minimum 5+ years of experience in Supplier Quality Engineering in FDA-regulated medical device manufacturing environments.
• Experience in supplier selection, performance assessment, PFMEA, SPC, SCAR, SICR, CAPA, and APQP/PPAP activities.
• Knowledge of medical device regulations and standards (21 CFR Parts 803, 806, 820; ISO 13485, ISO 14971; EU MDR; Canadian MDR).
• Strong data analytics and ability to drive supplier process improvements; excellent cross-functional communication.

Responsibilities

• Serve as the primary Supplier Quality Engineering contact for the Colorado Springs site.
• Lead APQP/PPAP, PFMEA, Control Plan, SPC, PV&V, FAI, IQ/OQ/PQ and related activities.
• Coordinate supplier qualification and onboarding for new suppliers and changes.
• Lead supplier audits and non-conformance investigations; drive CAPA and corrective actions.
• Drive supplier performance improvement using metrics and SCAR history.
• Collaborate with R&D, Manufacturing, and suppliers to improve design quality and manufacturability.

Skills

Supplier Quality Engineering

Data analytics

Cross-functional communication

Regulatory knowledge

APQP/PPAP

PFMEA

SPC

CAPA

SICR

Supplier audits

Education

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

ASQ Six Sigma DfX (Desirable)

Job description

Philips in Colorado Springs is seeking a Senior Supplier Quality Engineer to own supplier quality, compliance, and process capability across sustaining activities for the Image Guided Therapy Devices portfolio.

You will lead APQP/PPAP, PFMEA, SPC, SCAR/CAPA, supplier audits and qualification, coordinating with R&D, Manufacturing and suppliers to ensure robust designs, qualification readiness, and ongoing quality improvements.