Medical Device Auditor ISO13485

The British Standards Institution (BSI); Gemeinde Au; Remote; EUR 50 000 - 68 000; Vollzeit

Zusammenfassung

A leading standards organization is seeking an Auditor for Medical Devices. This role involves extensive training, travel for assessments, and writing detailed reports on quality management systems. Candidates should have a degree in a relevant field and at least 5 years of experience with medical devices. Local hire only. It’s a dynamic position that offers opportunities for professional growth.

Qualifikationen

• Degree educated in a relevant field like bioscience or biotechnology.
• Minimum of 5 years experience in medical device design or development.
• Local hire only.

Aufgaben

• Conduct training for ISO13485 and related standards.
• Travel across New Zealand and Australia for client assessments.
• Evaluate and report on quality management systems.

Kenntnisse

Medical device expertise

ISO13485 knowledge

Bioscience or Biotechnology background

Client management

Ausbildung

Degree in Bioscience or Biotechnology

Jobbeschreibung

Overview

Great that you're thinking about a career with BSI!

Auditor - Medical Devices

Location - New South Wales Australia (homebased)

About the role

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.

Responsibilities

What will I do?

• Undertake extensive training to deliver in your role, including ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
• As a Client Manager, be responsible for frequently travelling across New Zealand and Australia and some international travel may be required.
• Assess ISO13485 quality management systems and associated medical device regulatory requirements on customer sites or remotely, write up comprehensive reports and present these to the client.

Qualifications

• 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.
• Local hire only.

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.