Quality Manager

Job Description

Quality Management System (QMS) Implementation:- Develop and oversee the laboratory's Quality Management System (QMS) in compliance with standards such as ISO 15189, (Medical Laboratories Requirements for Quality and Competence) and IS0 17025 (standard for testing and calibration laboratories) Establish and update Standard Operating Procedures (SOPs) for all laboratory processes. Conduct regular internal audits to ensure adherence to quality standards. Quality Control (QC) and Assurance (QA):- Implement Internal Quality Control (IQC) and participate in External Quality Assurance (EQA)/Proficiency Testing (PT) programs to ensure test accuracy and reliability. Analyze QC data, identify trends, and take corrective actions if results deviate from acceptable ranges. Monitor and review the turnaround time (TAT) for test results to ensure timely reporting. Molecular Genomic Research, Institutional Services Diagnostics Ph. D/M.Sc. in life science (Biotechnology/Medical Microbiology/Microbiology/ Medical Biochemistry) with certification ISO 15189:2022 (Medical Laboratories Requirements for Quality and Competence) IS0 17025 (standard for testing and calibration laboratories) Minimum of 2/3 years work experience in Quality Management System (QMS) Implementation Regulatory Compliance:- Ensure compliance with national and international standards such as ISO 15189, IS0 17025 CAP (College of American Pathologists), NABL (National Accreditation Board for Testing and Calibration Laboratories), or local health regulations. Prepare the laboratory for accreditation assessments and audits. Maintain proper documentation and records for audits and inspections. Training and Competency Assessment:- Organize training programs for laboratory staff on quality standards, safety protocols, and SOPs. Conduct regular competency assessments of lab technicians and provide feedback. Promote a culture of quality and continuous improvement within the laboratory team. Handling Non-conformances and Risk Management:- Investigate non-conformities, errors, and customer complaints, identifying root causes and implementing corrective and preventive actions (CAPA). Maintain a system for reporting incidents such as sample mix-ups, equipment malfunctions, or test inaccuracies. Develop risk management strategies to prevent potential quality issues. Process Improvement and Data Management:- Use Quality Indicators (QIs) to monitor lab performance (e.g., TAT, error rates, sample rejection rates). Analyze trends and suggest continuous improvement initiatives (Lean, Six Sigma) to reduce errors and inefficiencies. Implement Laboratory Information Management Systems (LIMS) for proper record-keeping and tracking. Equipment Maintenance and Calibration:- Ensure that all laboratory equipment is calibrated, maintained, and validated according to standards. Maintain records of equipment performance and service history. Coordinate with vendors for proficiency testing materials and quality reagents. Customer Satisfaction and Feedback Management:- Collect and analyze feedback from patients, doctors, and other stakeholders. Address concerns and complaints promptly. Work with the lab team to improve service quality based on feedback.