SaMD QA Engineer
Halcyon Knights · Perth, Perth Region ·
- Category
- QA
A hands-on Quality Assurance Engineer for Software as a Medical Device (SaMD) at a medtech company in Perth, owning technical documentation, design control, risk and change management, and audit support for FDA 510(k)-cleared software. Works closely with software engineering, regulatory and product teams, applying standards like IEC 62304, ISO 13485 and ISO 14971.
An innovative 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 a…