Medical Device Quality Assurance Specialist

7 days ago


Gold Coast, Queensland, Australia BSI Full time

Explore a career where you can leverage your expertise to ensure patient safety and drive excellence in medical device manufacturing.

Salary: $120,000 - $150,000 per annum

Job Description:

We are seeking a skilled professional to join our team as a Client Manager. As a Client Manager, you will be responsible for assessing ISO13485 quality management systems and associated medical device regulatory requirements on customer sites or remotely.

Key Responsibilities:

  • Undertake extensive training to deliver in your role, including ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
  • 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.

Requirements:

To be successful in this role, you will need:

  • A degree in Bioscience or Biotechnology, with a Masters or equivalent qualifications.
  • A minimum of 5 years' experience in direct responsibility of either the design and development or research and development of an array of different medical devices.

Our Culture:

We value a collaborative and agile work environment at BSI. Our Excellence Behaviours: Client-centric, Agile, Collaborative represent how we do things at BSI.



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