About the Role
MoleMap is seeking a Software Quality & Validation Specialist to support the TGA application for their AI-enabled skin cancer technology. This role involves ensuring the product is appropriately tested, validated, and supported by clear technical evidence, while also ensuring requirements and documentation reflect genuine clinical, user, and business needs.
Responsibilities
- 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.
Requirements
- 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.
- Broader medical-device and Quality Management System experience is highly desirable but not required.
- 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.
Skills
- Software testing across user interfaces, APIs and integrations
- Test automation
- Version control
- CI/CD pipelines
- Familiarity with QA and defect-management tools
- Understanding of relevant ISO standards, regulated software requirements and validation frameworks
- Ability to design effective test cases
- Ability to analyse results
- Ability to investigate defects
- Ability to identify risks
- Clear technical documentation
- Effective reporting to technical and non-technical stakeholders
Work Type
- Fixed-term
Education Level
- A relevant degree in software engineering, computer science or a related field.
Salary/Compensations
- Competitive salary
Benefits
- Flexible working arrangement
About the Company
- 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
