Fixed-term until April 2027 | AI-enabled medical software
MoleMap is seeking a Software Quality & Validation Specialist to support the TGA application for our AI-enabled skin cancer technology.
Working with software, data science, clinical and regulatory teams, you will ensure the product is appropriately tested, validated and supported by clear technical evidence. You will also help ensure requirements and documentation reflect genuine clinical, user and business needs.
Broader medical-device and Quality Management System experience is highly desirable but not required.
Plan and coordinate software verification and validation activities.
Develop test plans, protocols, acceptance criteria and validation records.
Coordinate functional, integration and system testing across user interfaces and APIs.
Support the development of automated testing where appropriate.
Manage defects, retesting and supporting evidence through to closure.
Maintain traceability between user needs, software requirements, risks and testing.
Review technical documentation for accuracy, completeness and regulatory readiness.
Support software risk assessments, design reviews and release-readiness activities.
Prepare software evidence required for the TGA application.
Work with clinical and business stakeholders to ensure requirements reflect intended use and real-world workflows.
Help establish practical and effective quality and validation processes.
A relevant degree in software engineering, computer science or a related field.
Experience in software quality assurance, testing, verification or validation.
Experience with validation methodologies and compliance frameworks.
Experience producing structured technical documentation and test evidence.
Understanding of requirements, traceability and defect management.
Ability to work effectively with software engineers, data scientists and non-technical stakeholders.
Strong attention to detail and a practical, risk-based approach.
Ability to translate complex technical information into clear documentation.
Technical: Software testing across user interfaces, APIs and integrations; test automation; version control; CI/CD pipelines; and familiarity with QA and defect-management tools.
Regulatory and compliance: Understanding of relevant ISO standards, regulated software requirements and validation frameworks.
Analytical: Ability to design effective test cases, analyse results, investigate defects and identify risks.
Communication: Clear technical documentation and effective reporting to technical and non-technical stakeholders.
Experience in medical devices, healthcare or another regulated software environment.
Familiarity with Software as a Medical Device and Quality Management Systems.
Knowledge of ISO 13485, IEC 62304, ISO 14971 or TGA requirements.
Experience supporting regulatory applications or audits.
Experience with AI, medical imaging or cloud-based software.
Candidates are not required to have previously owned a medical-device QMS. Relevant QMS or regulated medical-software experience will be strongly regarded.
By April 2027:
Software requirements, risks, testing and outcomes are clearly traceable.
Validation evidence is complete and suitable for regulatory review.
Technical documentation accurately reflects the product and its intended use.
Required software evidence is ready to support the TGA application.
Competitive salary
Flexible working arrangement
The opportunity to do meaningful work with real health impact
A collaborative and ambitious team culture
The chance to grow your career in a high-growth business
