Job Description

Quality Assurance Engineer – Medical Devices

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Brisbane, QLD | Hybrid – 2–3 days office

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We're partnering with a global MedTech organisation to recruit a Quality Assurance Engineer into its Brisbane-based engineering team.

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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.

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The Role

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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.

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- Supporting design controls throughout the product development lifecycle
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- Developing and maintaining DFMEA / UFMEA and supporting risk management activities
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- Reviewing design documentation, specifications and V&V; records
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- Leading and supporting CAPA, root cause investigations and continuous improvement
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- Investigating product failures, complaints and non-conforming material
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- Supporting internal and external audits
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- Maintaining QMS procedures, work instructions and controlled documentation
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- Ensuring compliance with ISO 13485, ISO 14971,



FDA and other regulatory requirements
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- Supporting quality activities relating to Software as a Medical Device (SaMD)
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What We're Looking For

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Ideally, you'll bring:

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- 2+ years' Quality Assurance / Quality Engineering experience
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- Engineering or related technical degree
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- Experience within Medical Devices, Aerospace, Automotive or another highly regulated industry
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- Working knowledge of ISO 13485 and quality systems
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- Exposure to design controls and risk management
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- Strong technical documentation skills
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- Experience or exposure to Software as a Medical Device
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Experience with ISO 14971, FDA audits, eQMS, Lean/Six Sigma or CQE would be advantageous.

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Why Consider It?

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This isn't purely a compliance or documentation position.

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You'll be embedded within the product development environment and have the prospect to influence engineering and design decisions from a Quality perspective, while working on technology designed to improve patient outcomes.

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If you're a Quality Engineer / QA Engineer looking to build your career within MedTech, I'd be keen to hear from you.

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