Senior Supplier Quality Engineer – Med Device Compliance

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

Job summary

Philips seeks a Senior Supplier Quality Engineer to oversee supplier quality, compliance, and process capability for the Colorado Springs site. You will lead MSA, PFMEA, Control Plans, SP C, PV&V and APQP/PPAP activities to ensure supplier readiness and regulatory compliance, collaborating with R&D, manufacturing and suppliers.

The role requires 5+ years in medical device SQE, knowledge of 21 CFR 803/806/820, ISO 13485 and ISO 14971, and strong cross-functional communication.

Qualifications

• Minimum 5+ years in Supplier Quality Engineering within FDA regulated medical device manufacturing/supplier environments.
• Experience with PFMEA, SPC, SCARs, SICRs, CAPA and APQP/PPAP activities.
• Knowledge of medical device regulations and standards (21 CFR Part 803/806/820, ISO 13485, ISO 14971).
• Strong data analytics skills to assess supplier performance and drive improvements.

Responsibilities

• Lead APQP/PPAP execution for supplier transfers, changes, and sustaining projects.
• Lead supplier audits and qualification activities, and manage SCAR investigations.
• Coordinate supplier corrective actions and verify effectiveness of fixes.
• Drive systemic supplier improvements using performance data and NC trends.

Skills

5+ years experience

APQP/PPAP

PFMEA

SPC

SICR/CAPA

Data analytics

Cross-functional influence

Regulatory knowledge

Education

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

Job description

Philips seeks a Senior Supplier Quality Engineer to oversee supplier quality, compliance, and process capability for the Colorado Springs site. You will lead MSA, PFMEA, Control Plans, SP C, PV&V and APQP/PPAP activities to ensure supplier readiness and regulatory compliance, collaborating with R&D, manufacturing and suppliers.

The role requires 5+ years in medical device SQE, knowledge of 21 CFR 803/806/820, ISO 13485 and ISO 14971, and strong cross-functional communication.