The Calibration Lead is responsible for leading and managing calibration, testing, and validation activities for medical equipment to ensure accuracy, reliability, and compliance with applicable regulatory and quality standards. The role involves supervising calibration engineers, planning calibration activities, ensuring timely execution, maintaining documentation, and coordinating with hospital clients and internal service teams to support equipment performance and patient safety.
Key Responsibilities
1. Calibration & Validation
- Lead and oversee scheduled and preventive calibration of biomedical equipment, including ventilators, patient monitors, infusion pumps, defibrillators, and other critical medical devices.
- Ensure calibration activities are performed in accordance with OEM guidelines, applicable standards, and established procedures.
- Review and validate calibration results and certificates before submission to clients.
- Ensure proper utilization, maintenance, and traceability of calibration instruments and testing equipment.
2. Team Management & Supervision
- Supervise, guide, and allocate calibration activities to calibration engineers and technicians.
- Monitor team performance, productivity, and timely completion of assigned tasks.
- Provide technical guidance and training to team members on calibration procedures and troubleshooting.
- Ensure adherence to safety protocols and quality procedures during field activities.
3. Testing & Troubleshooting
- Oversee functional, performance, and electrical safety testing of medical equipment.
- Guide the team in identifying and resolving technical issues related to equipment performance.
- Ensure proper use and maintenance of electrical safety analyzers, patient simulators, and other testing equipment.
4. Quality Compliance & Documentation
- Ensure compliance with applicable ISO standards, NABL, NABH, and healthcare quality and safety requirements.
- Review and maintain calibration reports, certificates, equipment history, and service records.
- Ensure traceability of calibration instruments and timely renewal of their calibration certificates.
- Implement and monitor quality control procedures across calibration activities.
5. Audit & Quality Management
- Coordinate and support internal and external quality audits.
- Maintain audit readiness through accurate documentation and proper record management.
- Address audit observations and coordinate corrective and preventive actions (CAPA).
- Monitor non-conformities and ensure timely closure of quality-related issues.
6. Client & Operational Coordination
- Coordinate with hospital biomedical departments, service teams, and other stakeholders for calibration planning and execution.
- Manage client requirements, technical escalations, and calibration-related complaints.
- Plan manpower, resources, and schedules to ensure timely completion of calibration assignments.
- Prepare periodic reports on calibration activities, pending tasks, and team performance.
Skills & Qualifications
- Diploma / B.Tech in Biomedical Engineering, Electronics, or a related field.
- Relevant hands-on experience in medical equipment calibration, testing, and validation.
- Strong knowledge of biomedical equipment and calibration procedures.
- Good understanding of applicable ISO standards, ISO/IEC 17025, NABL, NABH, and healthcare safety requirements.
- Experience in handling calibration teams and managing field operations.
- Knowledge of calibration instruments such as electrical safety analyzers, patient simulators, and other testingequipment.
- Strong leadership, team management, and problem-solving skills.
- Excellent documentation, reporting, communication, and client coordination skills.
- Certification in medical equipment calibration or quality management is preferred.
Experience
3–5 years of experience in team handling / team leadership, along with relevant experience in medical equipment
calibration, testing, and validation. Candidates should have experience supervising calibration engineers or technicians
and coordinating calibration operations.