Clinical Laboratory Quality Manager

Role Overview

This position is the driving force behind the laboratory's quality management system, ensuring that every test, process, and record meets ISO 15189:2022 requirements and stands up to external scrutiny. Day to day, the role involves auditing, investigating problems, tracking performance data, and working alongside technical teams to fix issues before they affect patient results. The employer relies on this person to keep KENAS accreditation in good standing and to build a culture where quality is everyone's responsibility.

Key Responsibilities

• Own the laboratory's QMS, writing and updating policies, procedures, and work instructions so they stay aligned with ISO 15189:2022, and support staff training, competency assessment, and quality awareness.
• Lead preparation for KENAS accreditation and surveillance visits, including gap analyses, evidence packs, assessor logistics, and closing out any findings.
• Build and run the annual internal audit programme: schedule audits, brief and guide auditors, review their reports, and make sure corrective actions are followed through.
• Investigate nonconformities, incidents, complaints, and customer feedback using root-cause analysis, then design, track, and verify corrective and preventive actions until they are proven effective.
• Monitor quality indicators, internal quality control, and EQA/proficiency testing results with technical teams, flagging trends and driving improvement where performance dips.
• Keep document and record control systems tight so that current versions are accessible, obsolete ones are removed, and accreditation evidence is always audit-ready.
• Coordinate laboratory risk assessments and risk-management reviews, updating the risk register and escalating significant risks to management.
• Compile QMS performance reports, present them at management review meetings, and own the follow-up actions that come out of those sessions.

Requirements & Qualifications

• Bachelor's degree or higher in Medical Laboratory Sciences.
• 5–7 years of relevant experience working in a clinical laboratory.
• Demonstrated hands-on experience developing or running a laboratory Quality Management System.
• Working knowledge of ISO 15189:2022 and what it takes to pass an accreditation assessment.
• Practical experience conducting internal audits, managing nonconformities, and closing out corrective actions.
• Comfort interpreting EQA/PT and internal QC data, and using quality indicators to spot problems early.
• Strong documentation habits, report-writing skills, and the ability to present quality performance to laboratory management.
• Ability to work collaboratively with technical staff and influence quality practices at the bench.