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Quality Engineer for Software
2 weeks ago
We are collaborating with a pioneering company in the MedTech industry to drive life-changing innovation and real-world impact.
Key Responsibilities:- Review and approve technical documentation, including threat models, SBOMs, protocols, and architecture.
- Maintain risk assessments and traceability matrices for software compliance.
- Collaborate with software and systems engineers to ensure secure-by-design product development.
- Support secure software development lifecycle and Cyber Security efforts (IEC 81001-5-1, ISO 14971, FDA Cybersecurity Guidance etc).
- Support general QA activities - including CAPA, change control, document review, and internal/external audits.
- 5+ years of experience in software quality assurance in similar highly regulated industries.
- Experience with 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).
- Exposure to supporting or contributing to CAPA Investigations / Root Cause Analysis, Audit readiness or similar is beneficial.
- Exposure to Class III or implantable medical devices.
- Familiarity with UL 2900 and FDA Premarket Cybersecurity Guidance (2023).
- ISO 13485 training or experience.
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.
What We Offer:A dynamic and challenging work environment that fosters growth and development opportunities.
