Quality Assurance Manager

Vor 3 Tagen


Le Locle, Neuenburg, Schweiz Integra Lifesciences Switzerland SAS Vollzeit

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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