[Hiring] Medical Device Auditor @BSI

Role Description

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?

• Undertake extensive training to deliver in your role, including:
• ISO13485 Lead Auditor course
• MDSAP (Medical Device Single Audit Programme)
• MDR (Medical Device Regulation)
• Be responsible for frequently travelling across New Zealand and Australia, with some international travel required.
• 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.

Qualifications

• Degree educated (Bioscience or Biotechnology degree, Masters or equivalent qualifications).
• Education must be in a discipline relevant to medical device manufacture and use, containing modules relating to implantable devices.

Requirements

• Minimum of 5 years being directly responsible for 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.

Company Description

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.

• Partners with more than 77,500 clients in 195 countries.
• Engages with a 15,000 strong global community of experts, industry and consumer groups, organizations, and governments.
• Utilizes extensive expertise in key industry sectors, including automotive, aerospace, built environment, food and retail, and healthcare.
• Helps clients fulfill their purposes by tackling society’s critical issues.
• Dedicated to fostering a diverse and inclusive workplace.