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Quality Manager
2 weeks ago
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.
