Supplier Quality Assurance Specialist

vor 2 Wochen


Le Locle, Neuenburg, Schweiz Integra Lifesciences Switzerland SAS Vollzeit
Job Title: Supplier Quality Engineer

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.
Requirements:
  • 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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