Job Description

Position Summary

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

1. 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

2. Field Service Equipment Support

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

3. 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

4. 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

5. 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

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