Calibration Technician — Regulated Lab & Field Equipment

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, focusing 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 conditions, measurement uncertainty, and acceptability criteria. Field Service Equipment Support 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. Documentation & Compliance Accurately document calibration results in client systems (e.g., BMRAM or equivalent). Maintain complete and audit‑ready records, including calibration certificates and traceability to national/international standards (NIST, ISO). Investigations & Scheduling 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. Vendor & Internal Coordination 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. Equipment Maintenance & Troubleshooting Perform basic troubleshooting, repair coordination, and preventive maintenance. Identify equipment performance issues and escape as needed. Support root cause analysis for calibration failures or recurring issues. Qualifications Minimum Requirements Degree or relevant certifications preferred but not required. 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 and 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. #J-18808-Ljbffr MillenniumSoft Inc