Senior Quality Management Executive (IVF)

Quality Management System

• Develop, implement, and maintain the Quality Management System, including policies, Standard Operating Procedures, work instructions, and forms
• Manage document control, ensuring documents are reviewed, version-controlled, and accessible
• Track and report quality indicators, such as fertilisation, cleavage and blastocyst rates, implantation and clinical pregnancy rates, live birth rates, cycle cancellation rates, and patient satisfaction
• Prepare quality dashboards and present findings at management and quality review meetings

Regulatory and Licensing Compliance

• Ensure ongoing compliance with the Healthcare Services Act (HCSA) and its Assisted Reproduction Service regulations, and the MOH licensing conditions and directives that apply to the centre
• Support the Clinical Governance Officer and Principal Officer in meeting HCSA governance duties, including the quality assurance framework and incident reporting
• Ensure accurate and timely submission of ART data and notifications to MOH as required
• Ensure compliance with consent, embryo and gamete storage, and usage requirements, including storage duration limits and documentation of consent
• Monitor compliance with the Personal Data Protection Act (PDPA) for patient and donor records, and with the Workplace Safety and Health Act for liquid nitrogen, chemicals, and lab safety
• Track changes in MOH regulations, guidelines, and circulars, and update internal processes accordingly
• Liaise with MOH, accreditation bodies, and external auditors

Accreditation and Audit

• Coordinate preparation for MOH inspections and accreditation
• Plan and conduct internal audits across clinic, nursing, embryology lab, andrology, cryostorage, and administration
• Track findings through to closure using corrective and preventive action

Risk, Incident and Complaint Management

• Maintain the risk register and lead risk assessments for critical processes
• Support witnessing and traceability systems for gametes and embryos, including patient identification and chain of custody
• Manage incident, near-miss, and adverse event reporting including mandatory reporting to MOH where applicable
• Facilitate root cause analysis and follow up on corrective actions
• Handle patient complaints and feedback in coordination with the relevant teams

Laboratory and Nursing Equipment Quality

• Oversee maintenance, calibration, and validation records for incubators, cryobanks, LN2 monitoring, and air quality/VOC monitoring
• Support internal quality control, external quality assessment, and proficiency testing programmes
• Monitor supplier and consumables quality, including culture media, disposables, and lot traceability

The Experience and Expertise You'll Bring

• Bachelor's degree in Life Sciences, Biomedical Science, Nursing, Healthcare Management, or a related field
• 3 to 5 years in quality management, clinical governance, or regulatory compliance in a healthcare or laboratory setting in Singapore
• Experience in IVF, reproductive medicine, or an embryology or clinical laboratory is strongly preferred
• Working knowledge of HCSA requirements and MOH licensing processes
• Experience with internal audits and risk assessment
• Strong documentation, analytical, and report-writing skills
• Proficient in Microsoft Office and data analysis familiarity with QMS or document control software is an advantage
• Good communicator who can work with doctors, embryologists, nurses, and management
• Detail-oriented, with the integrity to handle confidential patient information