Quality Executive/Manager

Job Summary

We are looking for an experienced Quality Executive / Quality Manager to manage and strengthen quality systems across diagnostic laboratory operations. The candidate will be responsible for maintaining NABL accreditation requirements, implementing ISO 15189:2022 standards, conducting audits, managing documentation, and ensuring continuous quality improvement.

Key Responsibilities

• Manage and maintain the laboratory Quality Management System (QMS) in accordance with ISO 15189:2022 and NABL requirements.
• Ensure compliance with applicable NABL accreditation standards and procedures across laboratory operations.
• Coordinate and support NABL assessments, surveillance assessments, reassessments, and accreditation cycles.
• Should have participated in 35 NABL assessment/accreditation cycles.
• Handle internal audits, quality audits, and compliance audits and coordinate corrective actions.
• Identify Non-Conformities (NCs), perform root-cause analysis, and monitor CAPA implementation and closure.
• Prepare, review, and maintain quality-related SOPs, policies, manuals, formats, records, and controlled documents.
• Monitor and analyze Quality Indicators (QIs), laboratory errors, complaints, incidents, and process deviations.
• Ensure proper implementation of Internal Quality Control (IQC) and External Quality Assessment/Proficiency Testing (EQA/PT) requirements.
• Coordinate with laboratory departments to ensure adherence to defined quality standards and processes.
• Conduct regular quality training and awareness sessions for laboratory staff.
• Monitor equipment calibration, maintenance, validation, verification, and related quality documentation.
• Ensure proper handling of sample collection, identification, transportation, processing, testing, reporting, and result correction from a quality perspective.
• Participate in management review meetings and prepare quality-related reports and presentations.
• Drive continuous improvement initiatives to improve laboratory quality, patient safety, and operational efficiency.
• Ensure timely closure of observations and findings raised during internal and external assessments.
• Maintain readiness for NABL and other regulatory/accreditation assessments at all times.

Mandatory Skills & Qualifications

• Bachelor’s/Master’s degree in Medical Laboratory Technology, Life Sciences, Microbiology, Biochemistry, or a relevant discipline.
• Mandatory knowledge/certification in ISO 15189:2022.
• Candidate should have participated in 3–5 NABL accreditation/assessment cycles.
• Strong understanding of NABL requirements and ISO 15189:2022 standards.
• Hands-on experience in QMS implementation and maintenance in a diagnostic laboratory.
• Experience in Internal Auditing, CAPA, Root Cause Analysis, Risk Management, and Quality Indicators.
• Good understanding of IQC, EQA/PT, calibration, validation and verification.
• Strong documentation and audit-handling skills.
• Good communication and coordination skills.
• Ability to work with Pathology, Microbiology, Biochemistry, Hematology, Molecular Diagnostics, and other laboratory departments.