Metrology Specialist II (Calibration)

Job description

The Calibration Metrologist ensures the accuracy, reliability, and traceability of measurement and test equipment (M&TE) in compliance with FDA, GMP, ISO 13485, and ISO/IEC 17025 requirements. This role is responsible for performing, documenting, and coordinating calibration and maintenance activities to support manufacturing, quality control, and laboratory operations within pharmaceutical and medical device environments. - Perform routine and non-routine calibration, verification, and maintenance of measurement and test equipment (balances, pressure gauges, temperature sensors, dimensional tools, pH meters, and other analytical instruments). - Utilize standards traceable to NIST or equivalent; conduct in-house and coordinate external vendor calibrations. - Interpret calibration data, address measurement deviations, and implement corrective actions. - Maintain calibration records and ensure compliance with GMP, 21 CFR, ISO 13485, USP, IEC, and approved SOPs. - Support audits, impact assessments for out-of-tolerance findings, and deviation/CAPA investigations. - Develop and update calibration procedures and SOPs; assist with equipment validation and qualification. - Provide technic...