The Senior Calibration Supervisor – Clinical Devices is responsible for the strategic and operational leadership of the calibration function. This includes planning, executing, and validating the calibration of clinical instrumentation to ensure regulatory compliance, measurement traceability, and optimal device performance. The role involves team leadership, cross-functional coordination, vendor management, and direct interface with regulatory and quality assurance bodies.
This position is essential in environments where equipment accuracy is critical to patient safety and lab performance, and requires expert-level understanding of calibration, metrology, and audit-readiness in regulated clinical settings.
Lead and manage a team of calibration technicians and engineers responsible for routine and complex calibrations.
Develop, implement, and maintain the site-wide calibration program, ensuring alignment with international metrology standards.
Ensure traceability of all measurement equipment to national/international standards (NIST, NABL, etc.).
Own the Calibration Management System (CMS/CMMS) and ensure all data is accurate, audit-ready, and up to date.
Maintain calibration documentation per GxP, ISO 17025, FDA, CLIA, and CAP requirements.
Lead internal and external audit preparation, represent the calibration function during inspections, and close CAPAs.
Conduct risk assessments, define critical equipment calibration intervals, and manage out-of-tolerance investigations.
Manage third-party calibration vendors and service contracts.
Develop training programs and mentor junior supervisors and technicians.
Collaborate cross-functionally with Quality Assurance, Maintenance, Clinical Operations, and Validation teams.
Calibration Governance & Program Oversight
Design and enforce calibration SOPs, tolerance limits, and criticality assessments.
Implement a robust system for periodic reviews, compliance monitoring, and continuous improvement.
Compliance & Audit Readiness
Ensure full alignment with FDA 21 CFR Part 11, ISO 17025, CLIA, CAP, GAMP5, and Good Laboratory Practices (GLP).
Own and manage audit responses, deviation reporting, and CAPA processes.
Leadership & Team Development
Supervise and coach technicians and junior supervisors.
Build succession plans and ensure continuous skill upgrades through structured training.
Technical Mastery in Metrology & Instrumentation
Expert knowledge in calibration of:
Environmental chambers, incubators, centrifuges, refrigerators/freezers, thermocouples
Balances, pipettes, manometers, pressure and pH sensors
Evaluate calibration uncertainty and manage equipment life-cycle calibration data.
Strategic Collaboration & Risk-Based Planning
Participate in capital equipment selection with regard to calibratability and maintainability.
Drive calibration planning based on equipment criticality and historical performance.
System Ownership & Data Integrity
Ensure integrity and backup of calibration data across calibration management software (e.g., ProCal, Blue Mountain, SAP-PM).
Lead digital transformation initiatives where applicable (IoT, automated alerts, dashboarding).
Education:
Bachelor’s or Master’s in Instrumentation, Electronics, Biomedical Engineering, or related field.
Experience:
7+ years in equipment calibration or metrology roles.
3+ years in a supervisory or management role, preferably in a regulated clinical or diagnostics setting.
Certifications (preferred):
ISO 17025 Internal Auditor
ASQ CCT (Certified Calibration Technician) or equivalent
FDA compliance and GxP training certifications
Strong leadership and decision-making ability
Excellent written and verbal communication
Analytical mindset with focus on root cause analysis and continuous improvement
Collaborative working style across departments (QA, Maintenance, Clinical Ops)
Multispecialty hospitals and diagnostic chains
Clinical research organizations (CROs)
IVD or biotech manufacturing facilities
NABL-accredited calibration laboratories
Third-party calibration service providers for healthcare