Supplier Quality Engineer II
Integra LifeSciences · Facility, MA
QualityFull-time$71k–$98kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Supplier Quality Engineer II role at medical device manufacturer supporting contract manufacturers and raw material suppliers. Responsible for supplier audits, performance monitoring, CAPA management, compliance with FDA and ISO standards, and driving continuous improvement across supplier quality systems.
What they're looking for
- Bachelor's degree in Engineering, Life Science, or related technical discipline
- Minimum 3 years professional experience in GMP and/or ISO regulated industry
- Knowledge of ISO 13485, 21 CFR Part 820, and medical device regulations
- Strong analytical and root cause analysis skills
- ERP and PLM systems experience
- Microsoft Office proficiency
- Knowledge of statistical techniques
What you'll be doing
- Conduct supplier audits and maintain Approved Supplier List for contract manufacturers and raw material suppliers
- Manage supplier quality agreements, nonconformances, and change requests in compliance with regulatory requirements
- Monitor contract manufacturer performance metrics and provide quality engineering support to QC, purchasing, and production
- Support process validation activities, complaint investigations, and quality improvement projects
- Escalate supplier quality issues and develop compliant solutions in coordination with management
Privacy & handoff
This role links to Integra LifeSciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.