Quality Assurance Specialist

vor 1 Monat

Le Locle, Neuenburg, Schweiz Integra Lifesciences Switzerland SAS Vollzeit

At Integra Lifesciences Switzerland SAS, we are committed to creating a better future for healthcare. As a Supplier Quality Engineer, you will play a vital role in ensuring the quality of our products and services.

Your key responsibilities will include:

  • Providing quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Integra products
  • Establishing and ensuring the Approved Supplier List is up to date
  • Establishing timely planning and execution of supplier audits
  • Conducting Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements
  • Ensuring comprehensive measurement systems in place to monitor supplier quality/reliability, and to identify, correct and prevent defects
  • Establishing and ensuring Supplier Quality Agreements are up to date for applicable suppliers engaged in the production of Integra products
  • Reporting on contract manufacturer performance metrics
  • Ensuring technical support to QC, purchasing and production departments
  • Providing 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.
  • Addressing Supplier Change Requests in compliance with procedures and regulatory requirements.
  • Ensuring that activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timeline.
  • Ensuring that Supplier Non-conformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements.
  • Escalating supplier quality issues to management as appropriate, developing and proposing robust and compliant solutions.
  • Participating in and leading continuous improvement projects and initiatives.
  • Participating and supporting internal and third-party audits/inspections.
  • Managing or participating in quality projects as required.
  • Providing 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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