SaMD QA Engineer
Halcyon Knights · West Perth, Perth WA ·
- Work mode
- Hybrid
- Employment
- Full time
- Category
- QA
A hands-on quality engineer role at a Perth medical technology company with FDA 510(k)-cleared software: own controlled, traceable technical documentation, support design control, risk and change management across the software lifecycle, and liaise with engineering, regulatory and product teams. Key standards: IEC 62304, ISO 13485, 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 apply medical device quality requirements within a fast-moving software development environment.
Key Responsibilities
About You
Please apply directly or email [email protected]
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 fast-moving software development environment.
Key Responsibilities
- Develop and maintain technical and product documentation.
- Work closely with engineering teams to capture and document technical requirements and system information.
- Support documentation across the software development lifecycle.
- Maintain accurate, controlled and traceable documentation.
- Support design control, risk management and change management activities.
- Ensure documentation meets relevant quality and regulatory requirements.
- Support software releases, audits and continuous improvement activities.
About You
- Experience in technical writing within a software, engineering or regulated environment.
- A technical background or strong understanding of software/systems engineering.
- Experience within medical devices, healthcare technology or another regulated industry highly regarded.
- Knowledge of IEC 62304, ISO 13485 and/or ISO 14971 would be advantageous.
- Strong ability to interpret complex technical information and communicate it clearly.
- Comfortable working directly with engineering, quality and regulatory stakeholders.
- Based in Perth or willing to relocate.
Please apply directly or email [email protected]