Supplier Quality Assurance Specialist
vor 2 Wochen
Integra Lifesciences Switzerland SAS is seeking a highly skilled Supplier Quality Engineer to join our team. As a key member of our quality team, you will be responsible for ensuring the quality of our suppliers and contract manufacturers.
Responsibilities:- Provide quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Integra products.
- Establish and ensure the Approved Supplier List is up to date.
- Establish timely planning and execution of supplier audits.
- Conduct Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements.
- Ensure comprehensive measurement systems are in place to monitor supplier quality/reliability, and to identify, correct and prevent defects.
- Establish and ensure Supplier Quality Agreements are up to date for applicable suppliers engaged in the production of Integra products.
- Report on contract manufacturer performance metrics.
- Ensure 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. FDA CFR part 820 and ISO 13485 regulations/standards will be the focus.
- Address Supplier Change Requests in compliance with procedures and regulatory requirements.
- Ensure that activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timeline.
- Ensure that Supplier Non-conformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements.
- Escalate supplier quality issues to management as appropriate, develop and propose robust and compliant solutions.
- Participate in and lead continuous improvement projects and initiatives.
- Participate and support internal and third-party audits/inspections.
- Manage or participate in quality projects as required.
- Provide support with complaint investigations as required.
- A minimum of a Bachelor's Degree in an Engineering, Life Science, or a related technical discipline is required. Candidates with an equivalent combination of education and experience will also be considered for the position.
- 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.
- Auditing background is required.
- Lead Auditor certification to ISO 13485:2016 strongly preferred.
- Strong communication, teamwork, and organizational skills are essential.
- Strong analytical problem solving and root cause analysis skills.
- Use of ERP, PLM systems.
- Use of Microsoft office tools.
- Knowledge of statistical techniques.
- Experience or knowledge with the machining processes, injection molding, and/or electro-mechanical components/assembly is preferred.
- Willingness to travel as part of duties.
- Fluent in French and English.
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