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.