What you'll be doing
- Implement and maintain quality management system processes across medical device innovation projects
- Provide regulatory and quality guidance to project teams, including validation of unmet clinical needs, risk assessments, and de-risking of proposed solutions
- Ensure compliance with quality standards, regulatory requirements, and organisational policies, supported by accurate documentation and record-keeping
- Support project execution by monitoring milestones, preparing technical documentation, and ensuring alignment with grant deliverables and KPIs
- Collaborate with cross-functional teams to strengthen risk and quality practices in the development of safe and effective medical technologies
What we're looking for
- Masters/ Bachelor Degree level in Engineering/ Science
- 2 - 4 years of relevant working experience preferably with hands-on in risk management processes and quality management systems for medical devices
- Knowledge of ISO 13485, ISO 14971, IEC 62304 exposure to ISO 14155 and other medical device regulations/ standards is an advantage
- Experience with quality implementation/ maintenance and participation in ISO 13485 / IEC 62304 audits preferred
- Familiarity with the software development lifecycle and technical project coordination/ documentation
- Strong analytical, problem-solving, and technical writing skills
- Effective communicator, team player, and highly detail-oriented
Interested applicants, kindly furnish us with your full and detailed resume in MS Words format and click Apply Now button.
We regret to inform only shortlisted candidates will be notified. Applicants who do not possess necessary experience or qualification will still be considered on individual merits and may be contacted for other opportunities.
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EA License No: 10C4754
EA Personnel: Stephanie Toh
EA Personnel Reg No: R1217674
