Laboratory Quality Assurance Officer (QAO)

Role Overview

This position owns the day-to-day quality agenda of a medical laboratory operating under ISO 15189:2022, keeping the quality management system accurate, current and audit-ready at all times. The holder works across bench operations and documentation control, monitoring internal quality control and external quality assessment performance, investigating deviations at the root, and driving corrective actions through to verified closure. The role matters because accreditation standing, patient trust and the reliability of every reported result depend on someone systematically tracking conformance rather than reacting after the fact.

Key Responsibilities

• Monitor, analyse and interpret Internal Quality Control (IQC) and External Quality Assessment (EQA) data, escalating trends, shifts and outliers to laboratory leadership with clear written findings.
• Plan and conduct internal audits against ISO 15189:2022 requirements, document nonconformities, and follow each finding through to corrective and preventive action closure.
• Lead root cause analysis and risk assessment exercises for nonconforming work, incidents and process failures, and recommend risk-mitigating changes to laboratory procedures.
• Develop, review, revise, standardise and version-control laboratory Standard Operating Procedures, ensuring current approved documents are available at every workstation.
• Track quality indicators and performance metrics, compiling periodic quality reports that show progress on improvement initiatives and outstanding actions.
• Support external accreditation and surveillance audits, including preparation of evidence files, hosting auditors, and coordinating responses to assessor observations.
• Coordinate equipment-related quality activities, including routine maintenance schedules, troubleshooting records, malfunction reporting and verification of instrument performance.
• Maintain the document and records management system, ensuring audit trails, personnel competency records and quality activity logs are complete, accurate and retrievable.

Requirements & Qualifications

• Diploma or BSc in Medical Laboratory Sciences.
• Valid registration and licensing with the Kenya Medical Laboratory Technicians and Technologists Board (KMLTTB).
• A minimum of 3 years of post-training experience, demonstrating capacity to perform quality routine work including the analysis, review and interpretation of IQC and EQA data.
• Formal training in ISO 15189:2022 and in internal auditing based on ISO 15189.
• Demonstrated competence in root cause analysis, risk management and the use of quality indicators.
• Prior involvement in KENAS accreditation, surveillance audits, internal audits or QMS implementation is an added advantage.
• Proficiency in Microsoft Excel and other data management applications.
• Strong organisational skills, with the ability to maintain accurate records, coordinate multiple quality activities at once, meet deadlines and ensure systematic follow-up of audits, nonconformities, corrective actions and quality improvement initiatives.
• Proven technical ability in laboratory equipment operation, routine maintenance, troubleshooting and identification of equipment malfunctions.
• Ability to develop, review, revise, standardise, control and maintain laboratory Standard Operating Procedures.