Calibration Supervisor – Clinical Devices

The Mid-Level Calibration Supervisor – Clinical Devices is responsible for overseeing and executing the calibration of clinical and laboratory instruments to ensure measurement accuracy and regulatory compliance. This role supervises a small to mid-sized team of technicians, plans calibration activities, ensures traceability to national standards, and manages documentation required for regulatory inspections. The position demands a strong grasp of calibration science, regulatory frameworks, and equipment performance monitoring.

Key Responsibilities:

• Supervise calibration technicians in the execution of planned and corrective calibration tasks.

• Schedule and oversee calibration activities for clinical devices, including incubators, centrifuges, refrigerators, freezers, autoclaves, balances, pH/conductivity meters, and pressure and temperature sensors.

• Ensure traceability of measurements to NIST or ISO standards, maintaining calibration accuracy and documentation integrity.

• Maintain and update Calibration Management Systems (CMS) or CMMS software to track due dates, certificates, and asset histories.

• Review and approve calibration records, certificates, and deviation logs.

• Assist in regulatory audits (CAP, CLIA, ISO 17025, FDA) and ensure all procedures comply with internal SOPs and external standards.

• Coordinate external vendors for traceable calibration services and manage associated documentation.

• Train and mentor junior calibration technicians and ensure safety and SOP adherence.

Key Focus Areas:

1. Instrumentation Coverage & Calibration Depth

   • Manage calibration of:

     • Clinical lab instruments (centrifuges, pipettes, balances, CO₂ incubators)

     • Environmental systems (temperature/humidity sensors, data loggers)

     • Support equipment (autoclaves, refrigerators, ovens, manometers)

2. Compliance & Documentation Control

   • Ensure compliance with CAP, CLIA, ISO 17025, FDA 21 CFR Part 11, and GMP standards.

   • Maintain audit-ready documentation, including calibration schedules, certificates, and control charts.

3. Supervisory Duties

   • Lead a small team of calibration technicians.

   • Delegate and monitor daily calibration tasks.

   • Conduct on-the-job training and performance assessments.

4. Traceability & Measurement Standards

   • Ensure all calibrations are traceable to recognized metrology institutions (e.g., NIST, NABL).

   • Monitor and manage uncertainty budgets and tolerances.

5. System and Software Utilization

   • Operate and maintain calibration tracking systems (e.g., ProCalV5, Blue Mountain RAM, SAP-PM).

   • Generate reports and dashboards for management and compliance audits.

6. Audit and Risk Readiness

   • Support regulatory inspections and implement CAPAs for non-conformance issues.

   • Evaluate calibration failures, identify root causes, and recommend corrective actions.

Qualifications:

• Education:

  • Diploma or Bachelor’s in Instrumentation, Electronics, Biomedical, or Mechanical Engineering.

• Experience:

  • 4–6 years of experience in calibration of clinical/laboratory equipment.

  • At least 1–2 years in a supervisory or lead technician role.

• Certifications (preferred):

  • ISO 17025, Metrology Fundamentals, or Instrumentation Calibration Certification.

• Technical Skills:

  • Proficiency with calibration tools and reference standards.

  • Familiarity with regulatory documentation and compliance systems.