Quality Assurance Expert

1 day ago


Adelaide, South Australia beBeeExpertise Full time $90,000 - $100,000

Job Summary

We are seeking a Quality Assurance Expert to join our team. As a Quality Assurance Expert, you will play a crucial role in ensuring the safety and compliance of our devices.

About the Role
  • This is an excellent opportunity for individuals who want to work in a regulated medical device business and make a significant impact on the quality system.
Key Responsibilities
  1. Lead Quality Management Systems Operations: You will maintain and improve our quality system to support the business.
  2. Support Regulatory Pathways: Work with regulatory specialists to prepare documentation for FDA, MDR, and TGA approval.
  3. Enable Product Launch: Partner with product development and production to ensure design control and compliance are built-in from day one.
  4. Navigate Stakeholders: Build strong working relationships across regulators, suppliers, and auditors.
Requirements
  • 3+ years' experience in medical devices, pharma, or life sciences quality/regulatory roles.
  • Strong understanding of ISO 13485 and global regulatory environments.
  • Detail-oriented, proactive, and comfortable working in a fast-moving startup.
About Us

We offer a dynamic and supportive work environment that fosters growth and development.



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