QUALITY EXECUTIVE

Quality Executive

The Quality Executive supports theimplementation, maintenance and continual improvement of the laboratory QualityManagement System (QMS), and assists the Laboratory Manager in ensuringcompliance with applicable regulatory, accreditation and organisationalrequirements.

Key Responsibilities

• Support the implementation and maintenance ofthe laboratory QMS in accordance with MOH HCSA, ISO 15189 and other applicableregulatory and accreditation requirements.
• Monitor, compile and analyze laboratory qualityindicators and Key Performance Indicators (KPIs), prepare periodic qualityreports, identify adverse trends or areas of concern, and escalate findings tothe Laboratory Manager for review and follow-up.
• Coordinate the management of non-conformances,incidents, complaints and other quality events, including investigation, rootcause analysis (RCA), CAPA implementation and effectiveness review; monitoroutstanding actions and escalate significant or overdue issues to the ClinicalLaboratory Manager.
• Coordinate internal, regulatory andaccreditation audits, including audit preparation, documentation and evidencecollation, conduct of internal audits, tracking of findings and correctiveactions, and follow-up with relevant personnel to ensure timely closure.
• Maintain and update the laboratory quality andrisk registers, coordinate periodic risk reviews, monitor implementation ofrisk controls and mitigation measures, and escalate significant quality,regulatory and patient safety concerns, recurring non-conformances or overdueactions to the Clinical Laboratory Manager.
• Monitor Internal Quality Control (IQC),External Quality Assessment/Proficiency Testing (EQA/PT) and other qualityassurance activities, maintain relevant records and trend reports, and escalatesignificant or recurring issues for review.
• Support and coordinate validation, verificationand qualification activities for laboratory equipment, methods, processes andsystems, including maintenance of protocols, reports and associated qualityrecords.
• Coordinate and maintain change controldocumentation for changes affecting laboratory services, processes, equipment,systems and the QMS, and monitor completion of required actions.
• Administer the laboratory document controlsystem and coordinate the preparation, review, approval, distribution andperiodic review of policies, Standard Operating Procedures (SOPs), forms andother controlled documents.
• Coordinate quality-related training andcompetency activities, maintain relevant training and competency records, andfollow up on identified training requirements.
• Prepare quality data, reports and supportinginformation for management review and other quality meetings, maintain meetingrecords and track agreed action items to completion.
• Identify opportunities for continualimprovement through analysis of quality indicators, incidents, audit findings,CAPA and other quality data, and support implementation of approved improvementinitiatives.
• Maintain accurate and up-to-date qualityrecords and documentation to support regulatory, accreditation andorganisational requirements.
• Communicate and work with laboratory sectionsand relevant departments on quality matters and provide guidance on establishedQMS requirements and processes.
• Perform other quality-related duties asassigned by the Laboratory Manager.

Requirements

• Bachelor's Degree inChemistry, Biochemistry, Life Sciences or a related discipline.
• Relevant working experience ina clinical or healthcare laboratory environment
• Familiarity with ISO 15189 andMOH HCSA requirements applicable to clinical laboratory services
• Experience participating inregulatory and accreditation audits, including audit preparation and follow-upof findings
• Experience coordinatingclinical laboratory internal audits end-to-end — planning, conduct, reportingand CAPA follow-up through to closure
• · Experience managingnon-conformances / incidents and CAPA, including investigation, root causeanalysis and corrective action follow-up
• Familiarity with monitoringand reporting laboratory quality indicators, such as turnaround time (TAT),specimen rejection, critical result notification and other relevant KPIs
• Familiarity with EQA / PTparticipation, including performance monitoring, investigation ofunsatisfactory results and corrective follow-up
• Familiarity with laboratoryequipment management, including maintenance, calibration, validation /verification and associated documentation
• Familiarity with document andchange control processes
• Good organizational,communication and documentation skills

Advantageous

• Experience in qualityimprovement activities, including knowledge and application of relevant qualityimprovement tools and techniques
• Experience in coordinatingmeetings and preparing meeting minutes

Working Schedule

• Monday to Friday - 8.30 am to 5.00 pm
• Saturday - 8.30 am to 1.00 pm