Senior Supplier Quality Engineer – Medical Devices & Audits

DSM-Firmenich AG; Exton (PA); On-site; USD 115,000 - 125,000; Full time

Job summary

dsm-firmenich is seeking a Senior Supplier Quality Engineer in Exton, PA to lead supplier qualification, audits and quality improvements across product lines. This role partners with R&D, production and vendors to ensure compliant, robust supply chains and CAPA-driven improvements.

The successful candidate will have 8–12 years in regulated industries, ISO13485/21 CFR820 experience, and strong data analysis skills; mentoring the QA team and guiding external audits are key responsibilities.

Qualifications

• BS degree in engineering or equivalent.
• 8–12 years in quality engineering or supplier management in regulated industry.
• Experience with supplier qualification and audits.

Responsibilities

• Serve as primary quality contact with vendors of all sizes and complexities.
• Own and manage the supplier qualification process and Approved Supplier List.
• Develop, document, and implement QA procedures.
• Lead external audits of CMOs and suppliers and track actions.
• Establish Quality Agreements with supply chain partners.
• Analyze non-conforming materials and returned goods; recommend disposition.
• Lead root cause analysis for non-conformances and deviations.
• Review documentation for completeness and accuracy.
• Provide leadership and mentoring to supplier quality team.

Skills

Quality engineering

Supplier management

ISO 13485

21 CFR 820

Six Sigma

CQA/ASQ QE

Minitab

GMP knowledge

Education

BS Degree in Engineering

Tools

MS Office

Excel

Outlook

Job description

dsm-firmenich is seeking a Senior Supplier Quality Engineer in Exton, PA to lead supplier qualification, audits and quality improvements across product lines. This role partners with R&D, production and vendors to ensure compliant, robust supply chains and CAPA-driven improvements.

The successful candidate will have 8–12 years in regulated industries, ISO13485/21 CFR820 experience, and strong data analysis skills; mentoring the QA team and guiding external audits are key responsibilities.