Quality Assurance Engineer

Lead Group; City of Brisbane; Hybrid; AUD 90,000 - 130,000; Full time

Job summary

Lead Group in Brisbane, Australia, is seeking a Quality Assurance Engineer for Medical Devices to join a hybrid team (2–3 days in the office). You will support product development from design through commercialisation, focusing on design controls, risk management, and compliance with ISO 13485 and FDA requirements.

The role covers V&V activities, CAPA investigations, audits, and maintaining QMS documentation for SaMD projects.

Qualifications

• 2+ years of Quality Assurance/Quality Engineering experience in regulated environments.
• Experience with Medical Devices or SaMD desirable.
• Familiarity with ISO 13485 and design controls.

Responsibilities

• Support design controls throughout product development lifecycle.
• Develop and maintain risk management activities (DFMEA/UFM EA).
• Review V&V records and design documentation.
• Lead CAPA and root cause investigations; drive continuous improvement.
• Support internal and external audits and maintain QMS procedures.

Skills

Quality Assurance

Regulatory knowledge

Documentation

CAPA

V&V

Risk management

SaMD

ISO 13485

Education

Engineering degree

Job description

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 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 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.