Supplier Quality Engineer – Medical Devices (On-Site)

Philips Iberica SAU; Colorado Springs (CO); On-site; USD 63,000 - 100,000; Full time

Benefits offered by this job

Total Rewards benefits program

PTO

401k (up to 7% match)

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips Iberica SAU in Colorado Springs, CO is seeking a Supplier Quality Engineer to qualify suppliers, conduct audits, and lead APQP/PPAP activities for the Image Guided Therapies - Devices business.

The role requires 1+ years in supplier quality, familiarity with 21 CFR, ISO standards, and data analytics to drive improvements. This is an on-site role with travel up to 10% and relocation not offered.

Qualifications

• Minimum 1+ year in Supplier Quality/Quality Engineering in regulated environments.
• Knowledge of 21 CFR Part 803/806/820, ISO 13485, 14971; EU/Canada directives a plus.
• Experience using data analytics to drive supplier performance improvements.

Responsibilities

• Executes MSA, PFMEA, Control Plan, SPC, PV&V, FAI for APQP/PPAP and SICR.
• Supports PPAP/APQP deliverables including IQ/OQ/PQ at suppliers.
• Supports supplier improvement, guidance, and on-boarding for quality processes.
• Conducts supplier audits for qualification and for-cause with compliance checks.
• Qualifies new suppliers for Approved Supplier List and onboarding.
• Supports investigation and disposition of supplier non-conformances; CAPA.
• Initiates and coordinates SCAR processes with root-cause analysis.

Skills

Supplier Quality

Quality Engineering

APQP / PPAP

PFMEA

SPC

SCAR

CAPA

Risk Assessments

Data Analytics

Communication

Education

Associate's Degree

Bachelor's Degree (Desired)

Tools

MS Excel

Analytics Tools

Job description

Philips Iberica SAU in Colorado Springs, CO is seeking a Supplier Quality Engineer to qualify suppliers, conduct audits, and lead APQP/PPAP activities for the Image Guided Therapies - Devices business.

The role requires 1+ years in supplier quality, familiarity with 21 CFR, ISO standards, and data analytics to drive improvements. This is an on-site role with travel up to 10% and relocation not offered.