Software Quality Engineer

3 weeks ago

Gold Coast, Queensland, Australia WorkTrybe Full time
Software Quality Engineer (Medtech / Medical Devices)

Join to apply for the Software Quality Engineer (Medtech / Medical Devices) role at WorkTrybe

Software Quality Engineer (Medtech / Medical Devices)

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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 Software 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 Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionInformation Technology
  • IndustriesStaffing and Recruiting

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