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 (Implants) (Sydney)
🏢 Osseointegration International
📍 Sydney