Senior Supplier Quality Engineer Medical Devices APQP

Philips International; Reedsville (WI); On-site; USD 92,000 - 163,000; Full time

Benefits offered by this job

Generous PTO

401k match

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Senior Supplier Engineer-Ultrasound to drive supplier performance and quality throughout the product lifecycle in a highly regulated medical device environment.

You will lead APQP plans, perform PFMEA/SPC analyses, and collaborate with R&D and suppliers to ensure design-for-excellence and robust process controls. This onsite role requires travel and commuting distance to Reedsville, PA or Bothell, WA.

Qualifications

• Minimum of 5+ years’ experience in Supplier Engineering in highly regulated environments (Medical Device preferred).
• Knowledge of medical device regulations and standards (21 CFR 803/806/820, ISO 13485, ISO 14971, EU MDR, Canadian MDR).
• Experience with data analytics to assess supplier performance and drive process improvements.

Responsibilities

• Drive supplier performance and continuous improvement using APQP.
• Conduct DFMA/DFx reviews, PFMEA, Control Plans, SPC, PV&V and FAI with suppliers.
• Lead supplier approvals, SCARs, SICR, CAPA and remediation activities.
• Coordinate supplier submissions and line releases; maintain Approved Supplier List.
• Collaborate with R&D and suppliers to improve product design quality.
• Assess CtS/Q characteristics and ensure communication throughout production.

Skills

APQP processes

PFMEA

SPC

Risk assessments

Data analytics/KPIs

Cross-functional communication

Regulatory knowledge

Education

Bachelor's Degree in Quality, Engineering, or related disciplines

Job description

Philips is seeking a Senior Supplier Engineer-Ultrasound to drive supplier performance and quality throughout the product lifecycle in a highly regulated medical device environment.

You will lead APQP plans, perform PFMEA/SPC analyses, and collaborate with R&D and suppliers to ensure design-for-excellence and robust process controls. This onsite role requires travel and commuting distance to Reedsville, PA or Bothell, WA.