OrthoDx Pty Ltd, based in Sydney, seeks a Quality Manager to lead hands-on QA/QMS operations across ISO 13485:2016, EU IVDR, MDSAP, and FDA QSR frameworks. You will drive audits, CAPAs, document control, and risk management to ensure robust compliance as the company expands globally in orthopedics and IVD diagnostics.
Reporting into the leadership team, you will partner with regulatory and technical functions to maintain a state-of-the-art QMS, prepare for upcoming audits, and embed continuous