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Quality System Auditor – Medical Devices f/m

Altran AG

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Quality System Auditor - Medical Devices

Area of Responsibility:

  • Maintain internal audit process to ensure compliance with the appropriate regulations and standards (ISO 13485, 21 CFR Part 820-QSR, ISO 14971, CMDR, MDD, and International GMP guidance)

Conduct internal audit of QMS which includes the following:

  • Generate audit schedule, plans and reports
  • Conduct audits
  • Analyze quality system and adherence to criteria for management and control processes
  • Present and distribute the audit reports and observations to the process owners
  • Ensure that the corrections/corrective actions are appropriate and effective
  • Manage audit observations, audit reports through the audit database and CAPA process
  • Analyze the audit results and present the result at management review meeting
  • Identify, develop and implement improvements for the internal audit process/program
  • Participate in suppliers selection and evaluation process (i.e. on-site audit)
  • Incorporate the quality policy into all aspects of quality systems processes
  • Participate in Third Party Audits

Your Profile:

  • 4 years of experience in Regulatory Affairs or Quality Assurance
  • 4 years’ experience in medical device manufacturing
  • 4 years’ experience in quality systems auditing or ASQ-CQA and/or CBA certification
  • Effective oral and written communication skills
  • Comfortable interfacing with individuals from a variety of discipline
  • Effective presentation skills and technical writing skills Proficient in Sharepoint, Excel, Word, Visio
  • English fluent, German a plus