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 outstanding 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
Robust 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