Healthcare Senior/ Engineer, Quality & Risk (Medical Device Development) - #1120793

What you'll be doing

• Implement and maintain ISO 13485 and IEC 62304–compliant quality management system (QMS) processes across innovation and development projects

• Provide technical and regulatory guidance to project teams on medical device and software development

• Conduct risk assessments, validate unmet clinical needs, and ensure compliance with regulatory and organisational quality standards

• Support documentation control, audits, and record-keeping to meet project and grant KPIs

• Coordinate cross-functional activities to ensure timely completion of deliverables and milestones in alignment with regulatory and funding requirements

What we're looking for

• Bachelor’ Degree level in Engineering/ Science or related studies

• 2 – 4 years of working experience in quality management systems/ risk management processes, preferably with medical device design and development

• Hands-on experience with risk management processes for medical technology development

• Exposure to project coordination, technical project management, and technical documentation processes is desirable

• Familiarity with ISO 13485, ISO 14971, IEC 62304, ISO 14155, and relevant medical device regulations and standards

• Strong analytical, documentation, and communication skills with the ability to work collaboratively in a multidisciplinary environment

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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