Calibration Technician V

Responsibilities

• Collaborate with cross-functional teams, including R&D Engineering, Manufacturing Engineering, and Manufacturing, to support the Inspection, Measuring, and Test Equipment (IM&TE) calibration program in accordance with established directives, procedures, and policies.
• Accurately enter and maintain calibration asset data in the asset management tracking system.
• Perform and coordinate scheduled calibration activities in accordance with global directives, applicable regulations, and established procedures.
• Schedule and coordinate all internal and outsourced calibration services.
• Generate, maintain, and archive calibration records.
• Review contractor calibration certificates for completeness and compliance with established requirements.
• Document out-of-tolerance events and support root cause investigations and corrective actions.
• Create nonconformance records and assist with associated investigations and product/equipment dispositions.
• Communicate calibration schedules, equipment failures, and missing test equipment to affected departments.
• Follow standard operating procedures and provide recommendations for updates to work instructions and processes.
• Support internal and external audits related to calibration and equipment management activities.

Qualifications

• Required Education and Experience: High school diploma or equivalent with a minimum of four (4) years of experience performing calibration activities and coordinating calibration services with external laboratories. An Associate degree may substitute for two (2) years of the required experience. Associate or Bachelor's degree in a technical discipline preferred.
• Required Skills And Qualifications: Attention to Detail – Accurately documents calibration activities, discrepancies, and anomalies, and escalates out-of-tolerance conditions in accordance with established procedures. Mechanical Aptitude – Proficient in the use of precision measuring devices, including calipers, micrometers, and mechanical test fixtures. Electrical Aptitude – Proficient in the use of multimeters, variable autotransformers, electrical safety analyzers, and related test equipment. Calibration Expertise – Experienced in performing calibrations and maintaining calibration systems in accordance with established procedures and regulatory requirements. Regulatory Knowledge – Familiar with medical device calibration requirements within ISO 13485, ISO/IEC 17025, and applicable FDA Quality Management System Regulations (QMSR). Communication Skills – Effectively communicates technical information, reports out-of-tolerance findings, and participates in nonconformance investigations and corrective action activities. Problem Solving – Demonstrates the ability to analyze calibration discrepancies, identify root causes, and support effective corrective and preventive actions.
• Preferred Qualifications: ASQ Certified Calibration Technician (CCT) certification. Experience in a medical device or pharmaceutical manufacturing environment. Experience using Blue Mountain RAM software. Familiarity with 21 CFR Part 11 requirements for electronic records and electronic signatures.