Supplier Quality Engineer II: Elevate Medical Quality

Integra LifeSciences; Mansfield (MA); On-site; USD 71,000 - 98,000; Full time

Job summary

Integra LifeSciences in Mansfield, MA, seeks a Supplier Quality Engineer II to lead QA activities with contract manufacturers and raw material suppliers, ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and related regulatory requirements.

The ideal candidate will manage supplier audits, performance metrics, CAPA and change control, quality agreements, and provide technical support to QC, manufacturing, and purchasing to drive continuous improvement and reliable product supply.

Qualifications

• Bachelor’s degree in engineering, life science, or related technical discipline.
• Minimum 3 years of professional work experience in a GMP and/or ISO regulated industry.
• Knowledge of ISO13485, 93/42/EC, and 21 CFR Part 820 regulations.
• Strong communication, teamwork, and organizational skills.
• Experience with ERP, PLM systems and Microsoft Office; knowledge of statistical techniques.

Responsibilities

• Provide quality assurance leadership to select contract manufacturing sites and raw material suppliers.
• Establish and maintain the Approved Supplier List.
• Plan and execute supplier audits.
• Conduct supplier audits according to GMP, ISO standards and regulatory requirements.
• Establish and ensure Supplier Quality Agreements are up to date and manage supplier change control.
• Report on contract manufacturer performance metrics and provide support to QA, purchasing and production.

Skills

Communication skills

Teamwork

Organizational skills

Analytical thinking

Root cause analysis

Education

Bachelor's degree in Engineering/Life Science

Tools

ERP

PLM

MS Office

Statistical tools

Job description

Integra LifeSciences in Mansfield, MA, seeks a Supplier Quality Engineer II to lead QA activities with contract manufacturers and raw material suppliers, ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and related regulatory requirements.

The ideal candidate will manage supplier audits, performance metrics, CAPA and change control, quality agreements, and provide technical support to QC, manufacturing, and purchasing to drive continuous improvement and reliable product supply.