Quality Manager | Medical Devices (Implants) Osseointegration International
· Macquarie Park, NSW
· Full time OI designs and manufactures bone-anchored implants for amputees, including custom 3D-printed devices, supplied to surgeons in Australia, the US, Europe and Asia. What you’ll do
• Own and maintain our ISO 13485 QMS in Qualio
• Write, review and control SOPs, work instructions and forms
• Run CAPA, NCR, complaints and deviation processes through to closure
• Plan and lead internal audits, and host external audits (MDSAP, TGA, notified body)
• Manage supplier quality, including contract manufacturers and sterilisation
• Lead management review and quality metrics
• Support Regulatory Affairs on TGA and FDA requirements, including post-market surveillance




• Build the quality function as OI grows What you’ll bring
• 5+ years in a quality role in medical devices; strong pharma or GMP backgrounds also considered
• Hands-on ISO 13485 experience, ideally with MDSAP
• A track record of leading external audits and closing findings
• Working knowledge of ISO 14971 risk management, and TGA and FDA requirements
• Transparent writing and sound judgement, comfortable owning decisions in a small team Why OI The senior quality role in a growing medtech company, with direct access to the CEO and real ownership of how the function is built. Apply with your CV and a short note on an audit or CAPA you’re proud of.

📌 Quality Manager | Medical Devices (Sydney)
🏢 Osseointegration International
📍 Sydney