Senior Quality Engineer – Medical Devices | ISO 13485 | Validation

An innovative, venture-backed Australian MedTech company is at the forefront of developing groundbreaking medical technology designed to improve clinical decision-making and patient outcomes during childbirth. With a strong focus on innovation, the business is pioneering next-generation biosensor and monitoring solutions, tackling complex clinical challenges through cutting-edge engineering and technology.

Bringing together specialists across engineering, manufacturing, electronics, clinical research and data science, the business is continuing to develop and advance its creative medical technology.

They are now looking for a Senior Quality Engineer to join their multidisciplinary team based in Perth.

The Role

This is a hands-on quality engineering role working across medical device development, manufacturing, process validation and quality management systems.

You will play a key role in ensuring medical devices are designed, developed, validated and manufactured in accordance with ISO 13485 and FDA requirements.

Working closely with engineering, manufacturing and regulatory specialists, you will support product development, manufacturing readiness and regulatory submissions within a growing MedTech environment.

What You'll Be Doing

- Planning, developing and executing IQ/OQ/PQ protocols for manufacturing equipment and processes.
- Supporting medical device design controls, verification and validation (V&V;).
- Managing CAPA, nonconformances and root cause investigations.




- Maintaining and improving quality management systems (eQMS) in accordance with ISO 13485 and FDA requirements.
- Supporting design history files (DHF), risk management documentation and regulatory traceability.
- Qualifying and auditing suppliers, including incoming quality inspections.
- Supporting FDA 510(k), IDE and other regulatory submissions.
- Working closely with engineering and manufacturing teams on process validation, design transfer and continuous improvement.
- Supporting internal audits, regulatory inspections and ongoing compliance activities.

We're Looking For A Mix Of The Following:

- 5+ years of quality engineering experience within medical devices.
- Strong working knowledge of ISO 13485 and FDA quality requirements.
- Hands-on experience with IQ/OQ/PQ, process validation and V&V; activities.
- Experience managing CAPA, nonconformances and root cause investigations.
- Experience working with eQMS, document control and quality management processes.
- Understanding of design controls, DHF and risk management under ISO 14971.
- Experience with supplier quality, qualification and auditing.
- Exposure to FDA 510(k), IDE or TGA submissions would be advantageous.
- Experience in electronics or PCBA manufacturing, or knowledge of IEC 60601 and IEC 62304, would be advantageous but is not essential.
- Experience in biosensors, cleanroom manufacturing or a growing MedTech environment would also be highly regarded.

Next Steps
For more information and/or to be considered, apply now!

📌 Senior Engineer (Perth)
🏢 Halcyon Knights
📍 Perth