Quality Assurance Engineer – Medical Devices

Brisbane, QLD | Hybrid – 2–3 days office

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 innovative medical technologies from design through to commercialisation.

The Role

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

- 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
- 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.

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