Software Compliance Expert

1 week ago

Gold Coast, Queensland, Australia beBeeQuality Full time $130,000 - $175,000
Senior Quality Assurance Engineer (Medtech / Medical Devices)

Join a fast-growing scale-up in the MedTech/Medical Device space who are delivering life-changing innovation with real-world impact.

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.

  • 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 cybersecurity efforts (IEC 81001-5-1, ISO 14971, FDA Cybersecurity Guidance etc)
  • Supporting general QA activities - including CAPA, change control, document review, and internal/external audits

The ideal candidate will have a strong quality mindset, who thrives in highly regulated environments and can work closely with cross-functional teams.

Required skills include:

  • 5+ years in software quality engineering in similar highly regulated industries
  • Experience with the relevant standards and frameworks like IEC 62304, ISO 14971, IEC 81001-5-1, FDA QSR, ISO 13485, and relevant international guidance
  • Some knowledge of cybersecurity risk frameworks is beneficial (e.g. NIST, ISO 27001)

Nice to have:

  • Exposure to Class III or implantable medical devices
  • Familiarity with UL 2900 and FDA Premarket Cybersecurity Guidance
  • 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.

Relocation assistance is available.

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