Jobs · Manufacturing · California

Calibration Technician - Onsite (Urgent Need)

MillenniumSoft Inc · San Diego, CA · 2 mo ago
ManufacturingFull-time

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 BD 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
    • Carefully coordinate 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 client 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
    • Ot 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

Similar jobs