Medical Device Auditor ISO13485
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 is 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).
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 for 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.
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 fulfill theirs. 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.
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Medical Device Auditor Iso13485, Auckland
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Medical Device Auditor Iso13485, Auckland
New Zealand, Auckland, Auckland,
Modified October 20, 2024
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