Supplier Quality Assurance Specialist
Vor 7 Tagen
At Integra Lifesciences Switzerland SAS, we're committed to creating a better future for healthcare. As a Supplier Quality Engineer, you'll play a crucial role in ensuring the quality of our products and services.
Your Responsibilities:- Lead quality assurance initiatives for contract manufacturing sites and raw material suppliers.
- Develop and maintain the Approved Supplier List, ensuring it's up-to-date and compliant with regulatory requirements.
- Plan and execute supplier audits, conducting them according to good manufacturing practices, ISO Standards, and applicable regulations.
- Implement comprehensive measurement systems to monitor supplier quality and reliability, identifying and correcting defects.
- Establish and maintain Supplier Quality Agreements for applicable suppliers, ensuring they meet regulatory requirements.
- Report on contract manufacturer performance metrics, providing technical support to QC, purchasing, and production departments.
- Provide quality engineering support to suppliers, including audits, assessments, inspection technique support, verification/validation activities, CAPA, and change management.
- Address supplier change requests in compliance with procedures and regulatory requirements.
- Ensure activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timeline.
- Manage supplier non-conformances, initiating, dispositioning, approving, and investigating them according to plans and in compliance with procedures and regulatory requirements.
- Escalate supplier quality issues to management as appropriate, developing and proposing robust and compliant solutions.
- Participate in and lead continuous improvement projects and initiatives.
- Support internal and third-party audits/inspections.
- A minimum of a Bachelor's Degree in an Engineering, Life Science, or a related technical discipline is required.
- Experience working in a Medical Device manufacturing environment is preferred.
- Operations supplier quality experience is preferred.
- Minimum 3 years of professional work experience in a GMP and/or ISO regulated industry is required.
- Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820 is required.
- Auditing background is required.
- Lead Auditor certification to ISO 13485:2016 is strongly preferred.
- Strong communication, teamwork, and organizational skills are essential.
- Strong analytical problem-solving and root cause analysis skills are required.
- Experience with ERP, PLM systems, and Microsoft office tools is required.
- Knowledge of statistical techniques is required.
- Experience or knowledge with machining processes, injection molding, and/or electro-mechanical components/assembly is preferred.
- Fluent in French and English is required.
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