Medical Device Auditor ISO13485

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Auditor – Medical Devices

Location – New South Wales 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.
• 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).
• Local hire only.

About Us

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.

Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments. Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs. Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.