Quality Assurance Manager

We’re looking for a full-time Quality Assurance Manager to lead and scale the Quality function within our Software as a Medical Device (SaMD) organisation as we prepare for ISO 13485 certification and MDSAP audit.
This is a fully remote role within Australia, with domestic travel to Sydney required for audits.
This is a pivotal leadership role responsible for strengthening and operationalising a robust Quality Management System (QMS) that supports our AI/ML-enabled medical software products. You will play a central role in driving the organisation to certification readiness, ensuring our systems, processes, and culture meet global regulatory requirements including ISO 13485, FDA 21 CFR 820 (QMSR), MDSAP, and ISO 62304.
Working closely with Regulatory Affairs, Data Science, and Product Development teams, you will embed compliant yet pragmatic processes that support agile software development while ensuring audit readiness at all times.
Key responsibilities include:Leading the organisation’s preparation for ISO 13485 certification and MDSAP audit.Conducting gap assessments and driving remediation plans to achieve certification readinessOversee all quality processes and maintaining the QMSEmbedding ISO 62304-compliant processes within an agile SDLC environmentOverseeing software design controls, risk management (ISO 14971), software change control, configuration management and release proceduresLeading internal audit programs and management review processesDriving CAPA, nonconformance, complaint handling, and post-market surveillance systemsPartnering cross-functionally to ensure quality principles are embedded across Data Science and Product workflowsSupporting regulatory submissions and global market expansion initiatives
Desired Skills & ExperienceWe’re looking for someone who can build structure without slowing innovation, a pragmatic quality leader who understands both regulatory expectations and modern software development.
To be successful in this role, you will bring:Minimum 5–10 years’ experience in medical device Quality Assurance, with direct experience in Software as a Medical Device (SaMD).Strong working knowledge of ISO 13485, FDA 21 CFR 820 (QSR/QMSR), ISO 62304, and ISO 14971.Strong understanding of MDSAP requirements and audit preparation processes.Demonstrated experience supporting ISO 13485 certification audits.Hands-on experience implementing or scaling a QMS in a growth-stage organisation.Experience aligning quality systems with agile software development and release cycles.Experience managing software change control, configuration management, and release governance.Relevant tertiary qualification in Engineering, Science, Quality, or Regulatory Affairs
Highly desirable:Experience with AI/ML-enabled medical software.Experience with cloud-based or SaaS medical device platforms.Experience supporting FDA inspections or global regulatory submissions.