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; robust 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
Explicit 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 (Australia)
🏢 Osseointegration International
📍 Australia