| Detail | For this role |
|---|---|
| Department | Allied Health |
| Level | Mid level |
| Reports to | Lab Manager |
| Direct reports | None |
| Experience | 3 to 6 years in a clinical lab, with 1 to 2 years on quality or NABL work |
Quality Executive (Lab) job description template
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Job title: Quality Executive (Lab)
Department: Allied Health
Reports to: Lab Manager
Location: [City], [office, branch or site]
About the role
A Quality Executive in a diagnostic lab keeps the quality management system working every day, not only in the month before an audit. They manage internal quality control data, EQAS participation, document control, internal audits, non-conformities and corrective actions, and prepare the lab for NABL assessment under ISO 15189. The role does not run patient tests; it checks that the way tests are run, recorded and reported meets the standard.
Key responsibilities
- Maintain the quality manual, SOPs, forms and work instructions under document control, with version numbers and staff training records for every change.
- Compile daily and monthly IQC data for each analyser, prepare Levey-Jennings charts, and flag shifts and trends to section supervisors.
- Enrol the lab in EQAS and inter-lab comparison programs, dispatch samples on time, and drive corrective action for every unsatisfactory analyte.
- Plan and conduct internal audits covering pre-analytical, analytical and post-analytical processes at least once a year.
- Log non-conformities, complaints and incidents, and follow each corrective and preventive action to closure with evidence.
- Keep calibration and maintenance schedules for analysers, pipettes, centrifuges, thermometers and refrigerators, with certificates on file.
- Calculate monthly quality indicators such as sample rejection, turnaround time, critical value reporting and report amendments.
- Prepare data and minutes for management review meetings and chase the actions agreed there.
- Coordinate NABL applications, surveillance and reassessment visits, and compile evidence against each clause of the standard.
- Train staff on quality procedures, measurement uncertainty and revised SOPs, and keep attendance sheets for each session.
Requirements
- BSc or MSc in Medical Laboratory Technology, Biochemistry, Microbiology or Life Sciences
- ISO 15189 internal auditor training
- A laboratory quality management course is an advantage
- 3 to 6 years in a clinical lab, with 1 to 2 years on quality or NABL work
KRAs and KPIs for a Quality Executive (Lab)
Key result areas for the appraisal form, each with a KPI you can measure every month or quarter.
| Key result area | How to measure it |
|---|---|
| EQAS follow-up | EQAS reports reviewed within 7 days of receipt, with actions on every unsatisfactory result |
| Document control | No obsolete SOP or form found in use during any audit |
| Corrective actions | 90 percent of non-conformities closed with evidence within 30 days |
| Internal audit | Annual internal audit plan completed on schedule, covering every section |
| Calibration status | Zero equipment in use past its calibration due date |
| Quality indicators | Monthly quality indicator report issued by the 5th working day |
Skills and tools
Tools used day to day: Laboratory information system (LIS), QC data management software, MS Excel, Document control register, EQAS provider portals, Calibrated reference thermometers.
Reporting line and career path
Next roles: Lab Manager, Hospital Quality Manager, NABH Coordinator
Interview questions for a Quality Executive (Lab)
- What is the difference between a 2-2s and an R-4s Westgard violation, and what does each suggest?
- An EQAS result for TSH is outside acceptable limits. Take me through your investigation.
- How would you estimate measurement uncertainty for a biochemistry test?
- During an internal audit you find a technician using an old SOP version. What do you record and do?
- Which quality indicators would you report for the pre-analytical phase?
- How do you get busy section heads to close corrective actions on time?
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What does a quality executive do in a pathology lab?
A quality executive runs the lab's quality system day to day: IQC data and charts, EQAS participation, document control, internal audits, non-conformities and corrective actions, calibration schedules and quality indicators. They also prepare the evidence for NABL assessments and train staff on quality procedures.
What is NABL accreditation for medical labs?
NABL, the National Accreditation Board for Testing and Calibration Laboratories, accredits medical laboratories against ISO 15189. The standard covers management and technical requirements such as quality control, staff competence, equipment and reporting. Accredited labs are assessed at regular intervals, and the quality executive prepares much of the evidence.
What skills does a lab quality executive need?
The core skills are IQC statistics and Westgard rules, EQAS review, document control, internal auditing and root cause analysis. Good Excel skills help with charts and indicators. Just as important is the ability to get supervisors and technicians to close actions without having direct authority over them.