Quality Manager (Diagnostics Background)

Job Overview:

Quality Manager

Location - This is for our main Reference Lab, located in Kanakapura

Key Responsibilities:

Quality Management & Compliance:

• Establish, mplement, and continually improve the Quality Management System (QMS) in accordance with

  ISO 15189:2022

  and

  NABL guidelines

  .
• Maintain the

  quality manual

  ,

  organizational policies

  , SOPs, quality goals, and risk management strategies.
• Coordinate

  external quality assessments

  ,

  inter-laboratory comparisons (ILCs)

  , and

  proficiency testing (PT)

  .
• Monitor and analyze

  quality indicators (QIs)

  to identify trends and drive improvements.

Internal Audits & Risk Management:

• Plan and execute

  internal audits

  , root cause analysis, and implementation of

  corrective and preventive actions (CAPA)

  .
• Manage non-conformities, deviations, and complaints using structured documentation and follow-up.
• Ensure robust

  risk assessment and mitigation

  processes across pre-analytical, analytical, and post-analytical phases.

Accreditation & Regulatory Support:

• Serve as the primary liaison for

  NABL assessments

  ,

  surveillance audits

  , and

  regulatory inspections

  .
• Prepare documentation and ensure laboratory readiness for both initial accreditation and renewals.

Document & Data Control:

• Maintain effective

  document control

  , version management, change control logs, and retention schedules.
• Oversee secure data archiving practices in compliance with regulatory standards.

Training & Staff Competency:

• Organize regular

  quality training programs

  , onboarding modules, and awareness sessions for laboratory personnel.
• Ensure

  staff competency assessment

  as per ISO 15189:2022 guidelines and maintain training records.

Process Improvement:

• Promote a culture of

  continuous improvement

  and

  patient safety

  through internal benchmarking, lean initiatives, and customer feedback integration.
• Work with interdisciplinary teams to streamline lab operations, reduce errors, and improve turnaround time.

Equipment & Facility Oversight:

• Monitor and document

  equipment calibration

  ,

  maintenance

  ,

  validation

  , and

  environmental conditions

  as per defined schedules.
• Ensure traceability of measurement and control of reagents, consumables, and critical supplies.

Preferred Candidate Profile:

• Education:

  M.Sc./B.Sc. in Medical Laboratory Technology, Biochemistry, Microbiology, or related field.

• Experience:

  Minimum

  510 years

  in a NABL-accredited diagnostic laboratory, with at least 3 years in a quality management role.

• Certifications:

  ISO 15189:2022 Internal Auditor training, NABL assessor training (preferred).

• Skills:

• In-depthknowledge of ISO 15189:2022 and NABL accreditation process
• Strong analytical and documentation skills
• Proficiency in audit handling, CAPA, and risk management
• Excellent communication, leadership, and problem-solving abilities

Why Join Us?

Happiest Health