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Strategic Quality Leader

3 weeks ago

Melbourne, Victoria, Australia beBeeRegulated Full time $160,000 - $200,000

Quality Assurance Director

We are seeking an experienced strategic leader to fill a pivotal role. In this position, you will be responsible for maintaining and enhancing our Quality Management System (QMS) in alignment with ISO 13485, FDA 21 CFR Part 820, and other applicable international standards that govern the design, development, manufacture, and distribution of medical devices.

You will ensure ongoing ISO 13485 certification and global GMP compliance with regulatory bodies, including those in Australia, the US, EU, and other national authorities. You will provide regular reports to senior management on the effectiveness and performance of the QMS, playing a critical role in driving a culture of quality, compliance, and continuous improvement across the organisation.

Your key responsibilities include leading and managing the Quality Assurance, Post Market Surveillance, and Quality Control teams. You will continuously review and improve the QMS to ensure it fully reflects all processes involved in designing, developing, manufacturing and distributing our medical devices.

You will work closely with R&D, Regulatory Affairs, Clinical Research, and Production personnel to ensure Design History Files are created for all products, including dossiers appropriately formatted for regulatory submissions. You will maintain all controlled documents in accordance with documented procedures and ensure Batch Process Records, QC release testing, raw material/product reports, and labelling protocols are reviewed and maintained in accordance with defined manufacturing and QMS standards.

The successful candidate will have a degree in science, biomedical science/biotechnology, or a related discipline. They will have at least five years' experience managing Quality Assurance functions in a regulated environment, with a deep understanding of ISO 13485 and/or GMP (21 CFR 820). The ideal candidate will have proven leadership experience, with the ability to inspire, develop, and lead high-performing quality teams.

Requirements:

  • A degree in science, biomedical science/biotechnology, or a related discipline
  • At least five years' experience managing Quality Assurance functions in a regulated environment
  • A deep understanding of ISO 13485 and/or GMP (21 CFR 820)
  • Proven leadership experience

We Offer:

  • A dynamic work environment
  • Career development opportunities
  • Unlimited access to online learning
  • Rewards platform with access to discounts at various retailers
  • Paid parental leave for primary and secondary carers