Quality Assurance Engineer – Medical Devices
Brisbane, QLD | Hybrid – 2–3 days office
We're partnering with aglobal MedTech organisationto recruit aQuality Assurance Engineerinto its Brisbane-based engineering team.
This is a great opportunity for a QA professional who wants to work closer toproduct development and engineering, supporting innovative medical technologies from design through to commercialisation.
The Role
You'll act as a keyQuality representative across new product development and sustaining engineering programs, working closely with Engineering, Manufacturing, Regulatory and Product teams.
Supportingdesign controlsthroughout the product development lifecycle
Developing and maintainingDFMEA / UFMEAand supporting risk management activities
Reviewing design documentation, specifications andV&V; records
Leading and supportingCAPA, root cause investigations and continuous improvement
Investigating product failures, complaints and non-conforming material
Supportinginternal and external audits
Maintaining QMS procedures, work instructions and controlled documentation
Ensuring compliance withISO *****, ISO *****, FDA and other regulatory requirements




Supporting quality activities relating toSoftware 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 withinMedical Devices, Aerospace, Automotive or another highly regulated industry
Working knowledge ofISO *****and quality systems
Exposure todesign controls and risk management
Strong technical documentation skills
Experience or exposure toSoftware as a Medical Device
Experience with ISO *****, 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 prospect toinfluence engineering and design decisions from a Quality perspective, while working on technology designed to improve patient outcomes.
If you're aQuality Engineer / QA Engineerlooking 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