Senior Software Quality Assurance Specialist

1 day ago

Gold Coast, Queensland, Australia beBeeSoftware Full time $140,000 - $170,000
Job Description

We are seeking a Senior Software Quality Assurance Specialist to join our team in South East Queensland. As a key member of the software development lifecycle, you will be responsible for ensuring the quality and compliance of our medical device software.

Key Responsibilities
  • 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 81001-5-1, ISO 14971, FDA Cybersecurity Guidance)
  • Supporting general QA activities, including CAPA, change control, document review, and internal/external audits
Requirements
  • 5+ years of experience in software quality engineering in highly regulated industries
  • Experience with relevant standards and frameworks, including IEC 62304, ISO 14971, IEC 81001-5-1, FDA QSR, and ISO 13485
  • 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
Preferred Qualifications
  • 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, with opportunities for Brisbane-based candidates who can commute to site multiple days per week.

We offer relocation assistance for suitable candidates within Australia.

About the Role

This is a mid-senior level role that sits at the intersection of software compliance, security, and quality assurance. You will work closely with cross-functional teams to ensure the delivery of high-quality, compliant medical device software.

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