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 prospect for a QA skilled 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 new 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 , ISO ,



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 *
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 *, 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 chance 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.
J-*-Ljbffr

📌 Quality Assurance Engineer Queensland
🏢 Lead Group
📍 Queensland