Quality Associate

Exciting opportunity

Navier Medical is a growing software medical device company based in Perth. Our mission is to improve outcomes for patients at risk of heart attack, through AI-powered cardiac CT image analysis for cardiologists and radiology practices worldwide.

We’re looking for a Quality Associate to join the team and help us run and grow the quality system that underpins everything we do.

The role

You’ll be joining a passionate team in a fun and flexible environment where we like to kick goals! Working alongside our Quality Assurance & Regulatory Affairs Manager, you’ll be hands-on in the day-to-day running of our Quality Management System; keeping our documentation current, our records in order, and our processes working for the people who use them.

The role is based in Perth, with the flexibility to split your time between the office and home. We're looking for the right candidate and open to structuring this as a part-time or full-time position.

Your main responsibilities will be to:

- Maintain our electronic Quality Management System, including document control, change control and training records;




- Support our day-to-day quality processes – nonconformances, corrective and preventive actions, complaints, supplier management and design controls;
- Plan and conduct internal audits, and help prepare the Company for quality accreditations (such as ISO 13485, MDSAP);
- Compile and maintain the documentation supporting our regulatory submissions.

Your background

- Quality Assurance in a medical device or similarly regulated setting (3–5 years);
- Sound knowledge of ISO 13485, with hands-on experience in document control, internal audits and CAPAs;
- Software as a Medical Device experience (IEC 62304) and good understanding of managing information security (ISO 27001) will be looked upon favourably;
- Exposure to regulatory documentation is a bonus rather than a must – we’ll support you to grow here;
- You take pride in your work and have excellent communication skills (verbal and written).

Submit your application

Does this sound interesting and do you fit the role? Apply via LinkedIn with your resume and a brief note explaining why you’re the right person for the role.

📌 Quality Assurance Associate (Perth)
🏢 Navier Medical
📍 Perth