DxD Hub QARA Team is seeking candidate to join the QARA team to support QMS Implementation In design and development of software as medical device.

Selected candidate will receive training in the following areas :

• Understanding concept of ISO 13485:2016 standard and implementation of the standards to product design and development.
• Management of Change.
• Management of deviation and nonconformity.
• CAPA and root cause analysis.
• Key concepts In IEC 62304/ISO 14971/IEC 62366.
• Conducting risk assessment and usability engineering study.
• Documentation requirements in software design and development.

Candidate will provide QARA support In the followlng area s:

• QARA support for software development team in product design and development.
• Participate in audit, when applicable.
• Responsible for QA processes, for example, NCR and CAPA.
• Draft/review software validation protocol/report.
• Draft/review project document.
• Other QA operations role, for example, drafting and reviewing SOP, material inspection.
• Assist In cross functional work on ad hoc basis.

Job Requirement

• Bachelor of Science or Engineering.
• Candidates with no experience may apply.
• Basic knowledge in programming.
• Working knowledge In Microsoft office.
• Good communication skill.
• Basic presentation skill.
• Individual who is organized, highly motivated and results driven.
• Possess intellectual agility and a strong team player.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.