Hands‑on quality role within a global medical device business, offering exposure to complaints, CAPA, audits and international quality frameworks.

• Work across Class II medical devices with global regulatory exposure
• Hands on role influencing quality, compliance and patient safety
• High visibility in the function and great leadership

We’re partnering with a globally active medical device organisation that’s known for combining strong engineering capability with a genuine focus on patient outcomes. Operating in a highly regulated environment, the business develops and supports technology‑enabled solutions that are used internationally across clinical and healthcare settings.

This is a Quality Assurance Specialist role where you’ll play a hands‑on part in ensuring products meet global regulatory and quality standards, while working closely with cross‑functional teams across the full product lifecycle. It’s an ideal opportunity for someone who enjoys detail, structure and problem‑solving, but also values collaboration, continuous improvement and learning from great leadership.

Reporting into the RA & QA Manager, this role supports the quality management system for Class II medical devices, with exposure to multiple global regulatory frameworks, including FDA and EU.


In this role, you will be:

• Supporting product complaint investigations, trend analysis and post‑market surveillance activities
• Performing root cause analysis and contributing to effective CAPA implementation
• Supporting design control and change control processes across the product lifecycle
• Participating in risk management activities in line with ISO 14971
• Supporting supplier controls, including supplier evaluation based on risk
• Contributing to internal, external and supplier audits, including interactions with regulators and notified bodies
• Maintaining and improving quality system documentation such as SOPs, work instructions and forms
For those with a background in Software as a Medical Device, this role will be particularly attractive.


What you’ll bring to be successful in this role:

• A degree in Engineering, Life Sciences or a related discipline
• Around 3+ years’ experience in Quality Assurance (or QA/RA) within the medical device industry
• A strong working knowledge of FDA QSR, EU MDR, ISO 13485, MDSAP and TGA requirements
• Experience with complaint handling, supplier quality, audits, documentation and CAPA, including end‑to‑end Quality Assurance management
• Clear technical writing skills and the ability to communicate confidently across teams
• A detail‑oriented, organised and analytical approach

This role will appeal to someone who wants to be hands‑on but not siloed. You’ll be trusted with real responsibility and given the opportunity to apply your quality expertise in ways that genuinely influence products, processes and patient safety. Rather than being limited to document control or narrow tasks, you’ll be involved in investigation, problem‑solving and continuous improvement initiatives that matter.

Applications should be submitted in WORD format, or for a confidential discussion please contact Jasmine Garbino  0460 947 804