Internal Auditor Lead

6 days ago


Helsinki, Uusimaa, Finland Topconhealth Full time

Key Responsibilities

  • Act as Internal Auditor - ISO 13485:2016
  • Act as CAPA Leader; guide cross-functional teams through the process ensuring timely completion of CAPA
  • Take part in evaluating suppliers, subcontractors, external services, etc. on quality issues
  • Provide training on applicable QMS processes
  • Preparing and reviewing relevant documents e.g. in the Technical File
  • Participate in audits by external parties and resolve issues
  • Review labeling to determine compliance with labeling requirements
  • Support Post-Market Surveillance (PMS) activities

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