Senior Supplier Quality Engineer – Supplier Qualification & Validation

The Senior Supplier Quality Engineer, Supplier Qualification & Validation role at Integra LifeSciences supports the company's mission to improve healthcare outcomes by ensuring that contract manufacturers, raw‑material providers and component suppliers meet the highest quality standards. Integra develops and markets medical‑device products, and the position provides quality‑assurance leadership for supplier qualification, validation, monitoring and continuous development. On a daily basis you will lead supplier selection, qualification and onboarding, conduct risk‑based audits, and keep the Approved Supplier List current. You will design measurement systems that track supplier quality, reliability, delivery performance and process capability, and you will maintain Supplier Quality Agreements. The role also involves reviewing and approving validation plans, protocols and reports, managing non‑conformances, CAPA activities and root‑cause investigations, and providing technical quality support to Quality Control, Purchasing, Supply Chain, Engineering and Manufacturing teams. The position requires a bachelor's degree in Engineering, Life Sciences, Manufacturing, Quality or a related technical field, or an equivalent mix of education and experience. Candidates must have five to eight years of experience in Supplier Quality, Quality Engineering or related disciplines, including at least five years within a regulated medical‑device environment. Proven experience in new‑supplier qualification, ongoing supplier quality management, process and component validation, and a solid understanding of ISO 13485, EU MDR/MDD and FDA 21 CFR Part 820 are essential. Auditing experience is mandatory, and strong knowledge of GMP and risk‑based quality management is expected. Fluency in both French and English is required. Preferred, but not mandatory, skills include ISO 13485:2016 Lead Auditor certification, familiarity with machining, injection‑molding, extrusion, sterilisation and electromechanical assemblies, and experience with APQP, PPAP, Design Transfer or Supplier Development. Proficiency with ERP, PLM, Quality Management Systems and Microsoft Office, as well as statistical and quality‑engineering techniques, will aid success. The role may involve international travel and offers the chance to mentor junior engineers while contributing to continuous‑improvement projects that strengthen the supply chain. What the role asks for: - Bachelor's degree in Engineering, Life Sciences, Manufacturing or Quality - 5–8 years Supplier Quality or Quality Engineering experience - 5 years Medical‑Device manufacturing experience - Auditing experience in regulated environment - Knowledge of ISO 13485, EU MDR/MDD, FDA 21 CFR 820 - Fluent in French and English - ISO 13485:2016 Lead Auditor certification (preferred) - Experience with machining, injection molding, extrusion or sterilisation (nice‑to‑have)