Equipment Calibration and Qualification Technician

Equipment Calibration and Qualification Technician

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The Equipment Calibration and Qualification Technician performs calibration and qualification of research and manufacturing equipment, ensuring regulatory compliance with FDA’s 21 CFR Part 820 and ISO 13485, as well as other relevant standards. Responsibilities include calibrating equipment, executing qualification protocols, maintaining calibration records, coordinating external services, and supporting validation activities. The role requires hands‑on work with precision measurement tools, strong attention to detail, regulatory knowledge, and excellent documentation skills.

This full‑time, on‑site position also involves assisting with other Quality Assurance and validation tasks as needed.

Vice President of Quality Assurance & Regulatory Affairs

• Manage all calibration of manufacturing and laboratory equipment, including torque wrenches, pressure gauges, temperature sensors, analytical balances, micrometers, calipers, and other precision measuring instruments.
• Ensure all calibrated equipment is labeled and that calibration or qualification has not expired.
• Maintain accurate calibration records, certificates, and documentation in compliance with FDA 21 CFR Part 820 and ISO 13485.
• Update the equipment database with the current qualification and requalification status, using it to ensure the timely completion of all activities, whether performed internally or externally.
• Provide calibration and qualification status reports and metrics to management and support teams.
• Write, perform, and document equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Preventive Maintenance (PM).
• Support validation activities for new equipment, as well as modification or relocation of existing equipment.
• Support internal and external audits by providing calibration and qualification documentation, technical expertise, and responses to audit findings related to measurement systems and calibration processes.
• Participate in corrective and preventive action (CAPA) investigations related to calibration and qualification non‑conformances, equipment failures, and measurement system issues.
• Follow all company policies, procedures, and safety protocols when performing calibration and qualification activities in laboratory, manufacturing, and clean room environments.

• Proficient with precision measuring instruments, including micrometers, calipers, torque wrenches, pressure gauges, temperature sensors, analytical balances, and electronic test equipment for calibration activities.
• Strong computer skills, such as proficiency in Microsoft Office Suite for documentation, reporting, and data analysis, as well as experience with database systems for tracking equipment status, maintaining records, and generating reports and certificates.
• Experience with calibration principles, measurement uncertainty concepts, and statistical analysis of measurement data for equipment performance evaluation.
• Understanding of national and international measurement standards (NIST, ISO 17025) and traceability requirements for calibration activities.
• Familiar with medical device manufacturing regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices (GMP).
• Knowledge of equipment qualification processes (IQ/OQ/PQ) and validation documentation requirements in regulated manufacturing environments.
• Experience with metrology equipment maintenance, storage, and handling procedures to ensure measurement accuracy and equipment longevity.
• Ability to read and interpret technical drawings, specifications, calibration procedures, and equipment manuals for various measuring instruments.
• Problem‑solving abilities to troubleshoot calibration issues, identify root causes of equipment failures, and recommend corrective actions.
• Highly organized with strong attention to detail and time management skills.
• Excellent written and verbal communication skills for documentation, reporting, and…