Calibration Technician - Onsite

Job Description

The Calibration Technician is responsible for performing calibration, maintenance, and documentation of inspection, measurement, and test equipment (IM&TE) to ensure compliance with client Quality System requirements, FDA regulations (21 CFR Part 820), and ISO 13485 standards.

This role supports both internal laboratory equipment and field service equipment, with a focus on reducing calibration backlog, maintaining equipment readiness, and supporting audit readiness activities.

Key Responsibilities

• Calibration Execution (Core Function)

  • Perform calibration, verification, and adjustment of IM&TE including:
  • Electrical, mechanical, and dimensional equipment (e.g., Mettler balances, Instron systems, calipers, multimeters)
  • Execute calibrations in accordance with:
  • Approved procedures, work instructions, and specifications
  • Manufacturer requirements and traceability standards
  • Evaluate calibration results for:
  • Out-of-tolerance (OOT) conditions
  • Measurement uncertainty and acceptability criteria

• Field Service Equipment Support

  • Support calibration and control of field service and portable equipment
  • Ensure proper tracking, calibration status, and labeling prior to deployment
  • Cook up with Field Service teams to:
  • Maintain compliance for equipment used in customer environments
  • Resolve calibration-related issues impacting service operations

• Documentation & Compliance

  • Accurately document calibration results in BD systems (e.g., BMRAM or equivalent)
  • Maintain complete and audit-ready records, including:
  • Calibration certificates
  • Traceability to national/international standards (NIST, ISO)
  • Initiate and support investigations for:
  • Out-of-tolerance conditions
  • Calibration discrepancies or failures

• Calibration Scheduling & Coordination

  • Support execution of calibration schedules to meet due dates and reduce backlog
  • Interface with internal stakeholders and external vendors for:
  • Outsourced calibration activities
  • Equipment service and repair
  • Ensure timely turnaround of equipment to minimize operational impact

• Equipment Maintenance & Troubleshooting

  • Perform basic troubleshooting, repair coordination, and preventive maintenance
  • Identify equipment performance issues and escalate as needed
  • Support root cause analysis for calibration failures or recurring issues

Qualifications

• Minimum Requirements

  • Degree or relevant certifications preferred, but not required
  • Electronics, Mechanical Technology, Metrology, or related field OR
  • Equivalent experience
  • 3+ years of experience in calibration, metrology, or test equipment maintenance
  • Hands-on experience calibrating IM&TE in a regulated environment

• Preferred Qualifications

  • Experience in medical device, biotech, or pharmaceutical industry
  • Familiarity with:
  • FDA 21 CFR Part 820
  • ISO 13485 requirements
  • Experience with calibration and quality management systems (e.g., BMRAM, SAP, GAGEtrak)
  • Knowledge of:
  • Measurement uncertainty
  • Root cause analysis and OOT investigations

• Technical Skills

  • Strong understanding of:
  • Measurement science and calibration techniques
  • Electrical and mechanical instrumentation
  • Ability to read and interpret:
  • Technical drawings, specifications, and procedures
  • Proficiency with standard test equipment:
  • Multimeters, pressure gauges, scales, force testers, dimensional tools