Supplier Quality Engineer II
Integra LifeSciences
Integra LifeSciences seeks a Supplier Quality Engineer II to oversee quality assurance at contract manufacturing sites and raw material suppliers. The role involves supplier audits, compliance monitoring, quality agreements management, and continuous improvement initiatives across the medical device supply chain.
Responsibilities
- Provide quality assurance leadership to contract manufacturers and raw material suppliers
- Plan, execute, and conduct supplier audits per GMP, ISO standards, and regulatory requirements
- Maintain Approved Supplier List and Supplier Quality Agreements; monitor quality metrics
- Support validation of outsourced processes, manage supplier non-conformances, and lead change requests
- Lead continuous improvement projects and escalate quality issues with proposed solutions
Requirements
- 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 93/42 EEC standards
- Auditing background required; Lead Auditor certification to ISO 13485:2016 strongly preferred
- Medical device manufacturing environment experience preferred
- Fluent in French and English; willingness to travel
- Strong analytical and root cause analysis skills; ERP/PLM and Microsoft Office proficiency
Die Stellenanzeige wurde vor Vor 2 Tagen veröffentlicht
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