The Calibration Supervisor – Clinical Devices is responsible for managing and coordinating the calibration of all critical clinical and laboratory devices to ensure accuracy, compliance, and patient safety. The role oversees the execution of calibration schedules, supervises a team of calibration technicians, and ensures traceability and regulatory adherence across all measurement and monitoring equipment used in diagnostic and therapeutic processes.
The supervisor plays a key role in regulatory audits, process improvements, and preventive maintenance programs while maintaining strict control over documentation and calibration standards.
Supervise the calibration of temperature, pressure, humidity, pH, conductivity, flow, CO₂, weight, and timing devices used in clinical applications.
Ensure all equipment complies with regulatory standards like CAP, CLIA, FDA, ISO 17025, ISO 13485, and GMP.
Develop and implement calibration schedules, protocols, and procedures aligned with equipment criticality.
Maintain a comprehensive asset and calibration tracking system (CMMS).
Support and lead internal/external audits and participate in non-conformance investigations.
Oversee calibration traceability to national/international standards (e.g., NIST).
Train, supervise, and assess the performance of calibration technicians.
Approve calibration certificates, control charts, and deviation reports.
Ensure proper segregation and quarantine of out-of-tolerance or failed equipment.
Collaborate with QA/QC, laboratory operations, and vendors for compliant calibration solutions.
Regulatory Compliance & Standards Adherence
Maintain compliance with CAP, CLIA, ISO 17025, FDA 21 CFR Part 11, and cGMP.
Prepare documentation for inspections and audits by regulatory bodies and accreditation agencies.
Calibration Program Oversight
Manage routine and ad hoc calibrations across all clinical lab equipment.
Define criticality-based calibration intervals and tolerance limits for various devices.
Traceability & Documentation Control
Ensure all calibration data are traceable to NIST or equivalent international standards.
Maintain accurate records, certificates, logs, and calibration histories.
Instrumentation & Device Coverage
Focus on devices such as centrifuges, incubators, thermometers, freezers, balances, pH meters, pressure gauges, and CO₂ analyzers.
Oversee calibration of equipment supporting CIP/SIP, HVAC, autoclaves, and environmental monitoring systems.
Team Leadership & Development
Supervise calibration technicians, ensuring adherence to SOPs and safety practices.
Conduct skill assessments, training programs, and performance evaluations.
Audit Readiness & Risk Management
Lead responses to audit findings and implement corrective/preventive actions (CAPA).
Identify calibration-related risks and develop mitigation strategies (e.g., redundancy, backup devices).
Software & System Integration
Use CMMS, ERP, or calibration management software (e.g., Blue Mountain RAM, MasterControl, ProCalV5).
Ensure equipment interfaces are properly configured with LIMS or SCADA where applicable.
Education:
Diploma/Bachelor’s in Instrumentation Engineering, Biomedical Engineering, Electronics, or a related technical field.
ISO 17025 or Metrology training preferred.
Experience:
5–8 years of experience in clinical or laboratory calibration, with at least 2–3 years in a supervisory role.
Strong knowledge of calibration methodologies and applicable standards.
Skills & Competencies:
Proficiency in using reference standards, test instruments, and calibration software.
Understanding of Good Documentation Practices (GDP), CAPA systems, and audit processes.
Strong leadership, problem-solving, and organizational skills.