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.
Candidate will receive training in the following areas:
- Understanding concept of ISO 13485:2016 standard and the impact of the requirements on lab operations.
- Management of Change.
- Management of deviation and nonconformity.
- CAPA and root cause analysis.
- Key concepts in IEC 62304/ISO 14971/IEC 62366.
- Software life cycle.
- Software safety classification.
- Conducting risk assessment and usability engineering study.
- Documentation requirements in software design and development .
Candidate will be supporting the QA and lab operations team in the following:
- Provide QA support to the software development team in their design and development activities.
- Participate in audit, when applicable.
- Raise NCR, conduct CAPA process.
- 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 division work on ad hoc basis.
Job Requirements:
- Bachelor’s degree in Science or Engineering. Candidates with no experience may apply.
- Basic knowledge in programming.
- Working knowledge in Microsoft office.
- Good communication and presentation skill.
- Individual who is organized, highly motivated and results driven.
- Possesses 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.
