Quality Engineer - MedTech (SE Queensland)
Focus: Software Compliance & Quality Engineering
We're working with a fast-growing
scale-up in the MedTech/Medical Device space
who are delivering life-changing innovation with real-world impact.
Based in
South East Queensland
, this team is developing advanced implantable technology; with a focus on safety, security, and quality at every stage of the product lifecycle.
This role sits at the intersection of S
oftware compliance, Security and Quality Assurance
. It's ideal for someone who understands the complexity of regulated environments and wants to apply that expertise to meaningful technology.
You'll Be Involved In
* Reviewing and approving technical documentation; including threat models, SBOMs, protocols, and architecture
* Maintaining risk assessments and traceability matrices for software compliance
* Collaborating with software and systems engineers to ensure secure-by-design product development
* Supporting secure software development lifecycle and Cyber Security efforts (IEC, ISO 14971, FDA Cybersecurity Guidance etc
* Supporting general QA activities - including CAPA, change control, document review, and internal/external audits
A Bit About The Role
* It's a hybrid role with time split between hands-on software quality (around 80%) and broader quality system tasks (around 20%).
* We're after someone with a strong quality mindset, who thrives in highly regulated environments and can work closely with cross-functional teams.
* You'll need a mix of technical compliance expertise, strong documentation habits, and a collaborative approach to problem-solving.
Required
* 5+ years in software quality engineering in similar highly regulated industries
* Experience with the relevant standards and frameworks like:
* IEC medical device software - essential)
* ISO risk management)
* IEC cybersecurity for health software)
* FDA QSR, ISO 13485, and relevant international guidance
* Some knowledge of cybersecurity risk frameworks is beneficial (e.g. NIST, ISO 27001)
* Exposure to supporting or contributing to CAPA Investigations / Root Cause Analysis, Audit readiness or similar is beneficial
Nice to have:
* Exposure to Class III or implantable medical devices
* Familiarity with UL 2900 and FDA Premarket Cybersecurity Guidance (2023)
* ISO 13485 training or experience
Location & Flexibility: This is a hybrid role based on the
Gold Coast
; Brisbane-based candidates are welcome but must be able to commute to site multiple days per week to support collaboration and hands-on activities.
We are open and happy to support relocation from within Australia (relocation assistance is available)
For any direct contact; please reach out to