Senior Supplier Quality Engineer – On-Site Med Devices

Philips; Bedford (MA); On-site; USD 103,000 - 163,000; Full time

Benefits offered by this job

PTO (paid time off)

401k with match

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips in Bedford, MA seeks a Senior Supplier Quality Engineer to drive supplier performance and quality improvement across the product lifecycle in FDA-regulated medical devices. You will coordinate improvement initiatives, manage the ASL, and negotiate supplier quality agreements while leading audits and CAPA activities.

You will apply APQP, PFMEA, SPC and data analytics to assess supplier performance, determine root causes, and implement preventive actions.

Qualifications

• 5+ years in Supplier Quality Engineering within FDA regulated medical devices.
• Experience with supplier selection, APQP, PFMEA, SPC, SCARs and CAPA.
• Knowledge of 21 CFR Parts 803/806/820, ISO 13485, ISO 14971, EU MDR/EC, Canadian MDR.
• Ability to analyze supplier performance using KPI data and drive improvements.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Coordinate and execute supplier improvement initiatives; manage ASL and negotiate SQ agreements.
• Provide sustaining SQE activities for NCRs, SCARs, SCNs and ASL maintenance.
• Manage APQP with selected suppliers and conduct capability assessments.
• Lead trend analysis of product/process quality and troubleshoot issues.
• Oversee supplier qualification, change requests review and regulatory validation.
• Drive SCARs and preventive actions; act as internal and supplier auditor.
• Develop qualification and validation plans; lead improvement projects based on data.

Skills

Supplier quality

APQP

Risk PFMEA

SCAR/SCN/CAPA

Data analytics

Cross-functional comms

Education

Bachelor's degree in Quality/Engineering

Tools

SPC

Job description

Philips in Bedford, MA seeks a Senior Supplier Quality Engineer to drive supplier performance and quality improvement across the product lifecycle in FDA-regulated medical devices. You will coordinate improvement initiatives, manage the ASL, and negotiate supplier quality agreements while leading audits and CAPA activities.

You will apply APQP, PFMEA, SPC and data analytics to assess supplier performance, determine root causes, and implement preventive actions.