Your responsibilities:

• Provides quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Integra products
• Establishes and ensures the Approved Supplier List is up to date
• Establishes timely planning and execution of supplier audits
• Conducts Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements
• Ensures comprehensive measurement systems 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.
• Addresses Supplier Change Requests in compliance with procedures and regulatory requirements.
• Ensures that activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timeline.
• Ensures 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.
• Participates in and leads continuous improvement projects and initiatives.
• Participates and supports internal and third-party audits / inspections.
• Manages or participates in quality projects as required.
• Provides support with complaint investigations as required.

Your profile:

• 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