Medical Device Auditor ISO13485

Great that you're thinking about a career with BSI

Auditor – Medical Devices

Location – New Zealand/Australia (homebased)

Are you looking for a career where you can use your expertise to ensure patient safety?

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.

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.

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.