An cutting-edge medical technology company is looking for a SaMD Quality Engineer to join its growing team. With technology already FDA 510(k) cleared in the US, this role will support the continued development and commercialisation of regulated software products across international markets.
The successful candidate will take ownership of quality activities and work closely with Software Engineering, Regulatory and Product teams. This is a hands-on role suited to someone who understands how to apply medical device quality requirements within a rapid-moving software development environment.
Key Responsibilities
Support quality activities across the full software development lifecycle (SDLC).
Maintain design controls, requirements traceability and technical documentation.
Support software verification and validation.
Support risk management activities in line with ISO 14971.
Review software changes, defects and releases from a quality perspective.
Support CAPA, change control, audits and continuous improvement.
Work closely with Software Engineering teams to embed quality into development processes.
About You
Experience in SaMD, medical device software or regulated software development.
Solid understanding of IEC 62304.
Knowledge of ISO 13485 and ISO 14971.
Experience with design controls, software V&V; and requirements traceability.
Comfortable working closely with software developers and technical teams.
Exposure to FDA, TGA or international regulatory environments is highly regarded.
Experience with AI/ML medical devices or medical imaging software would be advantageous.
Currently based in Perth or willing to relocate to Perth.