Medical Device Auditor IVD ISO13485(home based)

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Position- Medical devices Auditor( IVD technical background preferred )

Location – New South Wales Australia(homebased)

Do you want variety and exposure to different medical device manufacturers and cultures?

Your next career could be as an auditor; or as we call them at BSI a Client Manager.

Our team in APAC are looking for medical device professionals who can demonstrate their expertise with design and/or manufacture or servicing of animal tissues in Medical Devices.

What will I do?

• Firstly, you’ll undertake extensive training to deliver in your role. This includes: ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
• Then as a Client Manager you’ll be responsible for frequently travelling across New Zealand and Australia and some International travel might be required.
• You’ll assess ISO13485 quality management systems and associated medical device regulatory requirements on customer sites or sometimes remotely, write up comprehensive reports and present these to the client.
• Experience with In Vitro Diagnostic (IVD) devices would be an advantage for this role.

To be a successful Auditor you’ll

• Be degree educated (Bioscience or Biotechnology degree, Masters or equivalent qualifications)
• Your education must be in a discipline relevant to medical device manufacture and use and contain modules relating to implantable devices.
• Have a minimum of 5 years being directly responsible of either the design and development or research and development, of an array of different medical devices.
• Strong background in in-vitro diagnostic medical devices, including both reagents and instruments, and their interfaces (experience can be - research, design and development, manufacturing, or testing).
• This position is open to local candidates only. BSI does not provide sponsorship for work permits.