Senior Supplier Quality Engineer - Medical Devices

Philips International; Northern (KY); Hybrid; USD 92,000 - 146,000; Full time

Job summary

Philips in Reedsville, PA is seeking a Senior Supplier Engineer to drive supplier performance and APQP across NPI, DFx collaborations with R&D, and ensure CtS/Q, PFMEA, and SPC compliance. You will assess supplier capabilities, manage APQP activities, and coordinate changes to the Approved Supplier List, with up to 10% travel for onsite work.

The role requires 5+ years in supplier engineering within regulated environments, strong regulatory knowledge (21 CFR, ISO 13485, ISO 14971), data

Qualifications

• Minimum 5+ years in supplier engineering in regulated environments (Medical Device preferred).
• Knowledge of medical device regs: 21 CFR 803/806/820, ISO 13485, ISO 14971, MDR.
• Proven experience with APQP, PFMEA, SPC, SCAR, CAPA, SICR.
• Ability to analyze data/KPIs to drive improvements.
• Bachelor's degree in Quality, Engineering or related field; ASQ Six Sigma DfX desired.
• Strong cross-functional communication with suppliers, R&D, and regulatory bodies.

Responsibilities

• Facilitate supplier capability assessments and selection.
• Develop and execute APQP plans for NPI to ensure product quality.
• Lead DFM/DFX reviews, PFMEA, Control Plans, and SPC.
• Oversee SCARs, CAPAs and supplier corrective actions.
• Maintain Approved Supplier List and perform supplier performance reviews.
• Coordinate regulatory compliance activities and audits.
• Collaborate with R&D on Design for Excellence initiatives.
• Travel up to 10% to supplier sites.

Skills

APQP

PFMEA

DFx

SPC

CAPA

SCAR

SICR

Regulatory knowledge

Data analytics

Cross-functional collaboration

Education

Bachelor's Degree in Quality/Engineering

Job description

Philips in Reedsville, PA is seeking a Senior Supplier Engineer to drive supplier performance and APQP across NPI, DFx collaborations with R&D, and ensure CtS/Q, PFMEA, and SPC compliance. You will assess supplier capabilities, manage APQP activities, and coordinate changes to the Approved Supplier List, with up to 10% travel for onsite work.

The role requires 5+ years in supplier engineering within regulated environments, strong regulatory knowledge (21 CFR, ISO 13485, ISO 14971), data