Supplier Quality Engineer II

About the role

Integra LifeSciences is looking for a Supplier Quality Engineer II to provide quality assurance leadership for its contract manufacturing sites and raw material suppliers producing Integra products. The role focuses on FDA CFR Part 820 and ISO 13485 regulations and standards, and involves auditing suppliers, managing supplier quality agreements and supporting continuous improvement.

Key responsibilities

• Provide quality assurance leadership for selecting contract manufacturing sites and raw material suppliers, and keep the Approved Supplier List up to date
• Plan and conduct supplier audits according to GMP, ISO standards and regulatory requirements
• Ensure measurement systems monitor supplier quality and reliability, and identify, correct and prevent defects
• Keep Supplier Quality Agreements current and report contract manufacturer performance metrics
• Support QC, purchasing and production, and support suppliers with audits, inspection techniques, verification/validation, CAPA and change management
• Address supplier change requests, validate outsourced processes and document non-conformances in line with procedures
• Escalate supplier quality issues, lead continuous improvement projects, support internal and third-party audits, and help with complaint investigations

Required profile

• Bachelor's degree in engineering, life sciences or a related technical discipline; equivalent education and experience also considered
• Minimum 3 years of professional experience in a GMP and/or ISO-regulated industry
• Preferred: medical device manufacturing experience, operations supplier quality experience, and auditing background
• Lead Auditor certification to ISO 13485:2016 strongly preferred
• Fluent in French and English; willingness to travel

Required skills

• Knowledge of ISO 13485, 93/42 EEC and 21 CFR Part 820
• ERP and PLM systems, Microsoft Office tools, and statistical techniques
• Root cause analysis and strong communication, teamwork and organizational skills
• Preferred: knowledge of machining, injection molding and electro-mechanical assembly