Quality Executive/Manager

MedPlus; Chennai District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

MedPlus is seeking an experienced Quality Executive / Quality Manager to strengthen quality systems across diagnostic laboratory operations. The role ensures NABL accreditation compliance, ISO 15189:2022 implementation, and ongoing quality improvements.

The incumbent will manage QMS documentation, audits, CAPA processes, and quality training across pathology, microbiology, biochemistry, and related departments. Strong collaboration and communication skills are essential.

Qualifications

• Must have ISO 15189:2022 knowledge/certification.
• Experience with implementing and maintaining QMS in a diagnostic laboratory.
• Participation in NABL accreditation cycles is required.
• Strong documentation, audit handling, and training capabilities.

Responsibilities

• Maintain QMS per ISO 15189:2022 and NABL requirements.
• Coordinate NABL assessments and accreditation cycles.
• Conduct internal/audit activities and drive CAPA closure.
• Prepare and manage SOPs, policies, and quality records.
• Monitor quality indicators, IQC, EQA/PT compliance, and training.

Skills

QMS

NABL/ISO15189

Auditing

CAPA

RCA

Documentation

Communication

Education

Bachelor’s/Master in MLT/Life Sciences/biomed

Job description

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.