Medical Device Auditor

1 month ago


Sydney, New South Wales, Australia Det Norske Veritas Full time
Job Title: Medical Device Auditor

As a Medical Device Auditor, you will be responsible for ensuring the quality and compliance of medical devices with regulatory requirements. Your expertise in ISO 13485 and EU MDR will be essential in conducting audits and assessments to ensure the highest standards of quality and safety.

Key Responsibilities:
  • Conduct onsite audits and assessments of medical devices to ensure compliance with ISO 13485 and EU MDR
  • Develop and implement audit plans to ensure timely and accurate reporting of audit results
  • Interact with customers at all levels of management to develop and implement corrective actions
  • Document and report audit and assessment activities and results
  • Provide timely and accurate reviews of customer corrective actions and closures
Requirements:
  • Bachelor's or Master's degree in Biomedical Engineering, Electrical, Electronic, Mechanical engineering, Bioengineering, Medical technology, Materials science, Biotechnology, Chemistry, or other related fields
  • EU MDR Lead Auditor certification
  • Minimum 4 years of experience in the medical devices industry, with at least 2 years in Quality Management
  • ISO 13485 audit experience (3rd party audit) for active medical devices
  • ISO 13485 Lead Auditor certification
  • Working knowledge of ISO 14971, medical device risk management
About Us:

DNV is a leading assurance and risk management company that helps companies manage risks and realize their long-term strategic goals. We work with companies worldwide to bridge trust gaps among consumers, producers, and suppliers.



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