Walk-in | Quality Manager : Medical Diagnostic Laboratory

Dr P Bhasin Path Lab; New Delhi; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Dr Bhasin's Lab in South Delhi is seeking an experienced Quality Manager from a pathology/medical diagnostic laboratory background to lead the Laboratory Quality Management System.

You will ensure compliance with ISO 15189 and NABL standards, supervise NABL documentation, internal audits, CAPA, RCA, and daily IQC with Westgard rules, Levey-Jennings charts, and QA indicators while collaborating with doctors and lab staff.

Qualifications

• Experienced in NABL-accredited medical diagnostics labs.
• Hands-on with ISO 15189 compliance and NABL documentation.
• Proficient in internal audits, CAPA, RCA and quality indicators.
• Strong QA/QC leadership in clinical biochemistry.
• Daily IQC review using Levey-Jennings and Westgard rules.

Responsibilities

• Manage the Laboratory Quality Management System per ISO 15189 and NABL.
• Prepare NABL documentation, SOPs, policies, formats and records.
• Oversee surveillance, reassessment, and audit preparation for NABL.
• Lead internal audits and close Non-Conformities (NCR).
• Drive Root Cause Analysis (RCA), CAPA and effectiveness checks.
• Configure management reviews and quality indicators reporting.
• Ensure calibration, verification, validation and maintenance docs for equipment.
• Oversee method verification/validation and lot-to-lot verification.
• Monitor EQAS/EQAP/proficiency testing and corrective actions.
• Train staff and assess competency; ensure QA/QC across all stages.

Skills

IQC knowledge

Levey-Jennings charts

Westgard Rules

CAPA/RCA

Laboratory QA

Quality indicators

Education

M.Sc./B.Sc. in Medical Lab/Biochemistry

Job description

QUALITY MANAGER MEDICAL DIAGNOSTIC LABORATORY

NABL / ISO 15189 / Clinical Biochemistry Quality Control

Location: Greater Kailash-I, New Delhi
Organisation: Dr Bhasin's Lab
Employment: Full-time, On-site

Dr Bhasin's Lab, a NABL-accredited medical diagnostic laboratory in South Delhi, is looking for an experienced Quality Manager specifically from a Pathology / Medical Diagnostic Laboratory background.

This is not a general QA/QC, pharmaceutical, manufacturing, food-testing or ISO 9001 quality role.

Primary Responsibilities

The Quality Manager will independently manage and continuously improve the Laboratory Quality Management System in accordance with:

• ISO 15189:2022
• NABL 112A / NABL 112B
• Applicable NABL requirements for Medical Laboratories

The role includes:

• Complete NABL documentation, records and document control
• Preparation/revision/control of Quality Manual, SOPs, policies, formats and records
• NABL surveillance, reassessment and audit preparation
• Internal audits and closure of Non-Conformities
• Root Cause Analysis (RCA), CAPA and effectiveness checks
• Management Review Meetings and Quality Indicators
• Equipment calibration, verification, validation and maintenance documentation
• Method verification/validation and lot-to-lot verification
• EQAS / EQAP / Proficiency Testing monitoring and corrective action
• Staff training, competency assessment and quality-system compliance
• Pre-analytical, analytical and post-analytical quality monitoring

Very Important Daily Analytical QC

The candidate must have hands-on knowledge of Internal Quality Control in a clinical diagnostic laboratory, particularly Clinical Biochemistry.

They should be comfortable independently reviewing:

• Daily IQC
• LeveyJennings charts
• Westgard Rules
• Mean, SD and CV%
• Shift and trend detection
• Bias and analytical variation
• Out-of-control events
• QC troubleshooting
• Corrective action before patient results are released
• EQAS/PT performance

Knowledge of automated Clinical Biochemistry and Immunoassay analysers is strongly preferred.

Candidate Profile

Preferred Qualification:

M.Sc. / B.Sc. in Medical Laboratory Technology, Biochemistry, Medical Biochemistry, Biomedical Sciences or another relevant Medical Laboratory discipline.

Mandatory Experience

Candidate should have:

• Experience working in a NABL-accredited Medical / Pathology / Diagnostic Laboratory
• Practical working knowledge of ISO 15189
• Experience handling NABL documentation and assessments
• Hands-on exposure to IQC and EQAS
• Understanding of Westgard Rules and LeveyJennings QC
• Experience with CAPA, RCA, Internal Audits and Quality Indicators

Previous experience as a Quality Manager / Deputy Quality Manager / Quality Executive / NABL Coordinator in a Medical Diagnostic Laboratory

will be strongly preferred.

Who Should NOT Apply

Candidates whose quality experience is predominantly in:

Pharmaceutical manufacturing, API/formulation manufacturing, food testing, cosmetics, automobile, engineering, construction, ISO 9001-only systems, industrial testing laboratories or other non-medical QA/QC functions without hands-on medical diagnostic laboratory experience should not apply.

What We Are Looking For

We need someone who can run the quality system, not merely maintain files.

The person should be comfortable walking into the laboratory every morning, reviewing IQC and analytical performance, identifying problems, ensuring corrective action, maintaining audit readiness and working directly with laboratory doctors and technical teams.

Relevant experience in Medical Diagnostics / Pathology Laboratory Quality Management is essential.