Quality Manager Medical Device jobs

Quality Manager – Diagnostics (Biochemistry & Hematology)

Location: Hyderabad (Base) | Oversight: Bengaluru & Mumbai | Type: Full-Time, DoctorC

Core Purpose

Drive clinical accuracy, regulatory compliance, and patient safety by managing the Laboratory Quality Management System (LQMS) for DoctorC’s Hyderabad hub and overseeing quality frameworks in Bengaluru and Mumbai.

Key Responsibilities

• Compliance & NABL Accreditation: Maintain NABL (ISO 15189) standards across all three city hubs. Lead internal/external audits and organize formal Management Review Meetings (MRM) with leadership.
• Technical Quality Control: Oversee daily Internal Quality Control (IQC) data (Westgard rules, Levey-Jennings) and External Quality Assessment (EQA/Proficiency Testing) for high-throughput biochemistry and automated hematology lines.
• Multi-Site Governance: Standardize SOPs across cities. Conduct periodic travel to Bengaluru and Mumbai for physical quality audits and equipment validation checks.
• Pre-Analytical & Logistics Control: Oversee and audit cold-chain logistics and temperature monitoring protocols for sample transit between collection points and hubs to eliminate pre-analytical errors.
• Safety & Risk Management: Monitor Bio-medical Waste (BMW) disposal, laboratory safety protocols, and staff health check compliance across all locations.
• CAPA & RCA: Investigate analytical errors or out-of-control QC runs. Implement robust Root Cause Analysis (RCA) and Corrective and Preventive Actions (CAPA).
• Efficiency: Align quality benchmarks with DoctorC's tech-driven Turnaround Time (TAT) targets.

Candidate Profile

• Education: B.Sc / M.Sc in Medical Laboratory Technology (MLT), Biochemistry, or Biomedical Sciences.
• Experience: 5+ years in clinical labs, with 2+ years in a dedicated Quality Management role under NABL guidelines. Multi-site oversight experience is preferred.
• Credentials: NABL Authorized Signatory status for Biochemistry and/or Hematology is highly desirable.
• Skills: Strong grasp of lab statistics (SD, CV%, Bias), LIMS platforms, and data-driven troubleshooting.
• Travel: Willingness to travel to Bengaluru and Mumbai labs as required (approx. 15-20%).

Key Success Metrics (KPIs)

• Audit Success: Zero major non-conformances during NABL audits.
• EQA/PT Scores: >98% acceptable performance rating across all sites.
• CAPA Resolution: 100% closure of logged deviations within 15 days.

Pay: ₹60,000.00 - ₹90,000.00 per month

Benefits:

• Health insurance
• Provident Fund

Work Location: In person