Software Quality Engineer

Software Quality Engineer (Medtech / Medical Devices)Join to apply for the Software Quality Engineer (Medtech / Medical Devices) role at Work Trybe Software Quality Engineer (Medtech / Medical Devices)1 day ago Be among the first 25 applicants Join to apply for the Software Quality Engineer (Medtech / Medical Devices) role at Work Trybe Get AI-powered advice on this job and more exclusive features.
Quality Engineer - Med Tech (SE Queensland)Focus: Software Compliance & Quality Engineering We're working with a fast-growing scale-up in the Med Tech/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 81001-5-1, 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.
Required5+ years in software quality engineering in similar highly regulated industries Experience with the relevant standards and frameworks like: IEC 62304 (medical device software - essential)ISO 14971 (risk management)IEC 81001-5-1 (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 scott.buddle@worktrybe.com Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Information Technology Industries Staffing and Recruiting Referrals increase your chances of interviewing at Work Trybe by 2x Get notified about new Software Quality Engineer jobs in Gold Coast, Queensland, Australia.
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