Quality Assurance Manager
Vor 3 Tagen
Your key responsibilities will include leading contract manufacturing sites and raw material suppliers in the production of Integra products.
Key objectives:
- Establish and ensure the Approved Supplier List is up to date.
- Plan and execute timely supplier audits.
- Conduct audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements.
- Monitor supplier quality/reliability.
- Establish and ensure Supplier Quality Agreements are up to date for applicable suppliers.
- Report on contract manufacturer performance metrics.
- Provide Quality Engineering Support to suppliers.
- Address Supplier Change Requests.
- Ensure validation of outsourced processes/products.
- Address Supplier Non-conformances.
- Escalate supplier quality issues to management.
Requirements:
- Bachelor's Degree in an Engineering, Life Science, or related technical discipline.
- Minimum 3 years of professional work experience in a GMP and/or ISO regulated industry.
- Knowledge of Medical device standards and regulations.
- Auditing background required.
- Lead Auditor certification to ISO 13485:2016 preferred.
Additional requirements:
- Strong communication, teamwork, and organizational skills.
- Strong analytical problem solving and root cause analysis skills.
- Knowledge of statistical techniques.
- Experience or knowledge with machining processes, injection molding, and/or electro-mechanical components/assembly.
- Willingness to travel as part of duties.
- Fluency in French and English.
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