You will assist to establish processes and work in a team to implement risk management best practices in innovation projects aimed at adoption and commercialisation. You will be involved in the implementation and maintenance of the office’s ISO13485-compliant quality management system processes and procedures in the department’s work and projects.
You will provide technical guidance and development support to the office’s ongoing medical technology development projects which include but are not limited to supporting validation of unmet clinical needs in projects, providing inputs to project teams on regulatory, quality and risk requirements, performing basic risk assessment of proposed solutions with consideration to regulatory requirements and conducting clinical need filtering and de-risking.
You will ensure compliance with quality, regulatory and organisation policies and systems and support record-keeping and documentation needed for compliance. You will manage and drive project tasks (including recommendation of grants) to ensure timely completion of project milestones (towards successful grant applications) and ensure that the projects meet KPIs set by the grant agency and manager.
Job Requirements
- PhD in Engineering or Science with relevant experience in quality management systems and/or risk management processes
- Master’s Degree in Engineering or Science with minimum 2 years of experience in quality management systems and/or risk management processes
- Bachelor’s Degree in Engineering or Science with minimum 4 years’ experience in quality management systems and/or risk management processes
- Experience in risk management processes for medical technology development
- Experience in implementation/maintenance of a quality management system
- Experience in QMS audit will be a strong advantage
- Familiarity with ISO 13485, ISO 14971, IEC 62304, ISO14155, Medical Device Regulatory, Medical Device Standards, Risk Management for Medical Devices
- Good problem-solving skills with strong technical writing focus
- Excellent communication and technical writing skills
- Meticulous, responsible, self-motivated and a good communicator
- Must be fully vaccinated against COVID-19
