Our client is a recognised leader in medical devices industry focusing on design, development and manufacturing of medical devices. The role will have to ensure full compliance, and solid product & process quality on design assurance of digital platform, software as medical device, health information and software component.
- Design and execute SW Quality plans by project level
- Provide guidance to teammates on processes & template requirements, and reviewing software design deliverable,
- Identifying project quality risks & process gaps and drive mitigation
- Setting up quality performance metrics of projects and convert them into actionable plan to drive project quality improvement,
- Responsible to review software tool validation to ensure the tools used in product development
- Supports organization's Q&R processes
- Bachelor's degree in Computer Science or Engineering
- 2+ years in a Software/firmware Development Quality Assurance or Design Verification Quality Assurance role
- Knowledge of applicable Medical Device Software Product Lifecycle and QMS standards (FDA, EU:MDR, IEC62304, ISO13485:2016, ISO14971, IEC62366)
- English speaking/reading/writing
If you are interested to learn more, please apply now or email for more information.