Senior Quality Expert

1 week ago


Sydney, New South Wales, Australia beBeeQuality Full time $70,000 - $100,000
Senior Quality Lead

We are seeking a highly skilled Senior Quality Lead to provide guidance and direction on product development activities.

This role will involve working closely with cross-functional teams to ensure adherence to guidelines and requirements of our quality management system.

  • Review product development documentation to provide input on compliance and quality of project deliverables.
  • Advise on suitable approaches for regulatory submissions for medical devices.

The ideal candidate will have a degree in Mechanical, Mechatronics or Biomedical Engineering, Industrial Design or a similar applicable technical discipline, with a minimum 5 years of experience in product development projects either in product development or quality assurance roles.

Experience working in an ISO 13485-compliant QMS and understanding of key Medical Device standards including ISO 14971 and IEC 62366 is highly desirable.

About the Role:

As a Senior Quality Lead, you will be responsible for ensuring the quality and compliance of our products.

You will work closely with our development teams to identify and mitigate risks, and ensure that all necessary documentation is in place.

If you have a passion for quality and a desire to make a real difference, we encourage you to apply for this exciting opportunity.

Key Responsibilities:
  • Lead the development of quality plans and procedures.
  • Conduct risk assessments and develop mitigation strategies.
  • Review and approve product development documentation.
  • Collaborate with cross-functional teams to ensure quality and compliance.


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