Calibration Technician - Onsite

millenniumsoftSan Diego, CA
Onsite

About The Position

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.

Requirements

  • 3+ years of experience in calibration, metrology, or test equipment maintenance.
  • Hands-on experience calibrating IM&TE in a regulated environment.
  • Strong understanding of measurement science and calibration techniques.
  • Strong understanding of 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.

Nice To Haves

  • Degree or relevant certifications preferred, but not required in Electronics, Mechanical Technology, Metrology, or related field OR equivalent experience.
  • Experience in medical device, biotech, or pharmaceutical industry.
  • Familiarity with FDA 21 CFR Part 820.
  • Familiarity with ISO 13485 requirements.
  • Experience with calibration and quality management systems (e.g., BMRAM, SAP, GAGEtrak).

Responsibilities

  • 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, specifications, manufacturer requirements, and traceability standards.
  • Evaluate calibration results for out-of-tolerance (OOT) conditions, measurement uncertainty, and acceptability criteria.
  • Support calibration and control of field service and portable equipment.
  • Ensure proper tracking, calibration status, and labeling of equipment prior to deployment.
  • Coordinate with Field Service teams to maintain compliance for equipment used in customer environments and resolve calibration-related issues impacting service operations.
  • Accurately document calibration results in BD systems (e.g., BMRAM or equivalent).
  • Maintain complete and audit-ready records, including calibration certificates and traceability to national/international standards (NIST, ISO).
  • Initiate and support investigations for out-of-tolerance conditions, calibration discrepancies, or failures.
  • Support execution of calibration schedules to meet due dates and reduce backlog.
  • Interface with internal stakeholders and external vendors for outsourced calibration activities and equipment service and repair.
  • Ensure timely turnaround of equipment to minimize operational impact.
  • 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.
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