As a Software Quality Assurance Engineer specialising in regulated medical device software, you will play a pivotal role in fostering a quality-driven culture across the organisation, with a strong focus on software solutions. Reporting to the Team Leader Quality & Regulatory, you will support the design, development, implementation, and continuous improvement of compliant, high-performing software within a robust Quality Management System (QMS).

The Software Quality Assurance Engineer applies specialist knowledge and regulatory expertise to ensure software development activities are conducted in accordance with applicable industry standards and regulatory requirements, including ISO 13485, IEC 62304, HIPAA, FDA (21 CFR Part 820/11), and global data security and privacy frameworks. This role is responsible for defining and implementing quality-focused approaches across the software development lifecycle (Agile, Waterfall, SAFe, DevOps), including the planning and execution of requirements, design, verification and validation strategies, and risk management activities.

Working cross-functionally with software development, engineering, and quality teams, the Software QA Engineer participates in and approves key design input and output deliverables, such as requirements, test plans, design reviews, and validation reports. The role also contributes to the implementation of quality methods, fosters traceability, and supports system-level risk analysis and software FMEAs throughout the regulated product lifecycle.

Principal Duties & Responsibilities / Key Accountabilities

Technical Support & Collaboration

Champion quality assurance throughout the software development lifecycle (SDLC), ensuring all activities align with US FDA Quality System Regulations (21 CFR Part 820/11), ISO 13485, IEC 62304, HIPAA, and global data security and privacy frameworks.

Collaborate cross-functionally with software development, engineering, and quality teams to ensure that software requirements, design, verification, and validation activities are planned, executed and documented in compliance with regulatory standards.

Define and implement quality-focused approaches across various SDLC methodologies (Agile, Waterfall, SAFe, DevOps), tailoring quality strategies to fit the chosen development model while maintaining regulatory compliance.

Participate in and approve key design input and output deliverables, including requirements specifications, test plans, design reviews, and validation reports, ensuring robust traceability and documentation throughout the product lifecycle.

Lead and support risk management activities, including system-level risk analysis, software FMEAs, and cybersecurity assessments, integrating risk controls into the development process in accordance with ISO 14971 and related standards.

Contribute to the creation and maintenance of design and development files, ensuring completeness and accuracy of development plans, verification and validation documentation and risk management files.

Support internal and external audits, including FDA inspections, by preparing documentation, participating in interviews, and addressing audit findings related to software quality and compliance.

Provide guidance and training to development teams on quality systems, SDLC frameworks and regulatory requirements, fostering a culture of continuous improvement and compliance.

Author and revise standard operating procedures (SOPs), work instructions and templates related to software quality engineering, SDLC, and computer system validation (CS).

Operations

Define and manage software environments (Dev/QA/Prod) and software version management across multiple classifications of software.

Assist in CAPA and complaint management related to software.

Participate in internal and external audits as the software development subject matter expert (SME).

Leadership

Lead software quality reviews and participate in all phases of the software development life cycle, ensuring alignment with FDA and IEC 62304 expectations.

Contribute to the implementation and improvement of quality-focused methods, processes and procedures across software development.

Communication & Stakeholder Management

Provide clear and effective communication across departments to ensure shared understanding of software quality and compliance requirements.

Communicate changes in regulatory expectations and their impact on internal procedures.

Support cross-functional teams in preparation for audits, design reviews and regulatory submissions.

Health and Safety

Take all actions to avoid, eliminate or minimise workplace hazards.

Record, document and report hazards, incidents and injuries, as required in line with state OHS legislation.

Assist in the development and documentation of Risk Assessments, Standard Operating Procedures (SOPs) and Safe Work Management Systems (SWMS) for equipment and activities that could pose an OHS risk.

Promotes a positive safety culture and commitment to efficient OHS practices throughout the Vitrafy Life Sciences business.

Provides ongoing recommendations for the company’s OHS improvements.

Key Selection Criteria

Qualifications & Experience - Essential

Bachelor’s or higher degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.

3–5+ years of experience in software quality engineering or quality assurance within the FDA-regulated medical device industry, with hands-on involvement in SaMD or SiMD projects.

In-depth knowledge of relevant standards and regulations, including 21 CFR Part 820/11, ISO 13485, IEC 62304, ISO 14971, and HIPAA.

Demonstrated experience with both Agile and Waterfall SDLC methodologies, and the ability to adapt quality processes to fit hybrid or evolving development models.

Strong proficiency in risk management, requirements management, verification and validation, and documentation best practices for regulated software.

Experience supporting audits, CAPA, complaints and QMS activities related to software products.

Excellent communication, technical writing, and interpersonal skills, with the ability to partner effectively across functions and levels of the organisation.

Strong knowledge of GMP and regulatory requirements for Australia, Europe and USA.

Qualifications & Experience - Desirable

Familiarity with AI/ML-based medical device software quality management and emerging regulatory frameworks for digital health and artificial intelligence.

Experience with tools such as JIRA, DOORS, Jama, GitHub, and eQMS platforms for requirements, issue tracking and quality documentation.

Advanced working knowledge of cybersecurity risk management and data privacy requirements in medical device software.

Technical/Professional Knowledge & Skills

Strong time management skills, with the ability to prioritise multiple deadlines without jeopardising quality of work.

Innovative thinker with ability to create, review and optimise operational processes.

Proficient in recording, analysing and interpreting data.

Excellent attention to detail, advanced analytical and conceptual skills.

Experience in collaborating with technical and clinical colleagues to complete work tasks.

Ability to work autonomously and as part of a collaborative team.

Personal Attributes

Adaptability: Maintains effectiveness when experiencing changes in work responsibilities or environment; adjusts effectively to work within new structures, processes, requirements or culture.

Work Standards: Sets high standards of performance for self and others; assumes responsibility and accountability for successfully completing assignments or tasks; self-imposes standards of excellence rather than having standards imposed.

Stress Tolerance: Maintains stable performance under pressure or opposition (time pressure, job ambiguity); handles stress in a manner that is acceptable to others and to the organisation.

Managing Work: Effectively manages one’s time and resources to ensure that work is completed efficiently and to expectations.

Positive Outlook: Enthusiastically works with others and represents Vitrafy Life Sciences in a professional manner.

Dedication: Integrates quickly with the team and identifies how one’s role contributes to Vitrafy Life Sciences’ sustained success.

Interpersonal Skills

Communication: Excellent written and oral communication skills and the ability to work well with cross-functional teams.

Building Strategic Working Relationships: Develops and uses collaborative relationships to achieve work goals.

Superior problem-solving skills: Ability to negotiate successful outcomes under challenging circumstances.