Quality Assurance Engineer – Medical Devices

? Brisbane, QLD | Hybrid – 2–3 days office

? Permanent, Full-Time

We’re partnering with a global MedTech organisation to recruit a Quality Assurance Engineer into its Brisbane-based engineering team.

This is a great opportunity for a QA professional who wants to work closer to product development and engineering , supporting cutting-edge medical technologies from design through to commercialisation.

The Role

You’ll act as a key Quality representative across new product development and sustaining engineering programs , working closely with Engineering, Manufacturing, Regulatory and Product teams.

Your responsibilities will include

- Supporting design controls throughout the product development lifecycle
- Developing and maintaining DFMEA / UFMEA and supporting risk management activities
- Reviewing design documentation, specifications and V&V; records
- Leading and supporting CAPA, root cause investigations and continuous improvement
- Investigating product failures, complaints and non-conforming material
- Supporting internal and external audits
- Maintaining QMS procedures, work instructions and controlled documentation
- Ensuring compliance with ISO 13485, ISO 14971, FDA and other regulatory requirements




- Supporting quality activities relating to Software as a Medical Device (SaMD)

What We’re Looking For Ideally, you’ll bring:

✔️ 2+ years' Quality Assurance / Quality Engineering experience

✔️ Engineering or related technical degree

✔️ Experience within Medical Devices, Aerospace, Automotive or another highly regulated industry

✔️ Working knowledge of ISO 13485 and quality systems

✔️ Exposure to design controls and risk management

✔️ CAPA / root cause investigation experience

✔️ Strong technical documentation skills

✔️ Experience or exposure to Software as a Medical Device

Experience with ISO 14971, FDA audits, eQMS, Lean/Six Sigma or CQE would be advantageous.

Why Consider It?

This isn't purely a compliance or documentation position.

You'll be embedded within the product development environment and have the opportunity to influence engineering and design decisions from a Quality perspective , while working on technology designed to improve patient outcomes.

If you’re a Quality Engineer / QA Engineer looking to build your career within MedTech, I’d be keen to hear from you.

? Message me directly for a confidential discussion.

📌 Quality Assurance Engineer (Brisbane)
🏢 Lead Group
📍 Brisbane