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 chance 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 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

Strong technical documentation skillsExperience 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.

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