Senior Supplier Quality Engineer (SQE) - Medical Devices
Our client, a global leader in medical devices, is looking for a Senior Supplier Quality Engineer (SQE) to strengthen supplier quality systems, lead validation activities, and drive continuous improvement. This role is ideal for an experienced quality professional who thrives in a dynamic, hands-on environment and enjoys mentoring others while ensuring compliance with FDA and ISO standards.
What You’ll Do
- Lead supplier quality strategy, process improvements, and QMS activities.
- Support and validate supplier transfers, equipment, and measurement systems.
- Drive PPAP, supplier qualification, and change control processes.
- Collaborate cross-functionally to streamline operations and eliminate redundancies.
- Provide on-site oversight during manufacturing transfers and supplier transitions.
- Mentor and coach peers on process validation activities.
- Manage supplier remediation (SCARs, CAPAs, nonconformances) and maintain the Approved Supplier List (ASL).
- Participate in supplier audits and performance reviews.
What We’re Looking For
- Bachelor’s degree in Engineering or related field.
- 8+ years of supplier quality experience in the medical device industry.
- Strong background in validation (process, equipment, measurement systems).
- Experience with PPAP, supplier transfers, and change control.
- Working knowledge of FDA regulations & ISO 13485.
- Excellent communication, problem-solving, and technical writing skills.
Seniority level
Employment type
Job function
- Medical Equipment Manufacturing