Quality Manager | Medical Devices (Implants)

Osseointegration International; Sydney; On-site; AUD 120,000 - 180,000; Full time

Job summary

Osseointegration International in Sydney, NSW, is seeking a Quality Manager for Medical Devices (Implants) to own and scale our ISO 13485 QMS, collaborate with regulatory affairs, and drive quality across suppliers.

You will lead internal audits, manage CAPA/NCR with closure, and build the quality function as the company grows, reporting to the CEO in a fast-paced medtech environment. This role offers direct impact on patient safety and product quality.

Qualifications

• 5+ years in a quality role in medical devices or pharma/GMP backgrounds considered.
• Hands-on ISO 13485 experience, ideally with MDSAP.
• Proven track record leading external audits and closing findings.
• Working knowledge of ISO 14971 risk management and TGA/FDA requirements.
• Clear writing, sound judgement, and ownership in a small team.

Responsibilities

• Own and maintain 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.

Skills

Quality management

ISO 13485

External audits

Risk management

Regulatory knowledge

Tools

Qualio

Job description

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


• Clear 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.