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Quality Manager

2 weeks ago


Bengaluru, Karnataka, India Happiest Health Systems Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Job Overview:

We are looking for a seasoned and meticulous Quality Manager to oversee and enhance the Quality Management System (QMS) of our Clinical Diagnostic Laboratory in alignment with ISO 15189:2022 standards and NABL accreditation requirements. This role is central to ensuring technical competence, continual improvement, and regulatory compliance across all testing activities.

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?

At Happiest Health, youll be part of an organization committed to transforming healthcare by integrating scientific excellence, technology, and human empathy. As a Quality Manager, youll play a critical role in establishing one of India's most reliable and future-ready diagnostic services.