Calibration Technician - Medical Device Complexus Medical - 3.3 Mishawaka, IN Job Details Full-time 1 hour ago Qualifications Mechanical blueprint interpretation Technical documentation ISO standards Regulatory compliance Equipment troubleshooting Laboratory equipment calibration Parts drawings Biomedical regulatory compliance Technical troubleshooting support Quality control calibration Measurement (quality control) Full Job Description We are seeking a skilled Calibration Technician to support our quality and manufacturing operations in a regulated medical device environment . This role is responsible for performing calibration, maintenance, and documentation of measurement and test equipment to ensure compliance with quality standards, including ISO 13485 and applicable regulatory requirements. The ideal candidate will have hands-on experience in calibration and metrology within the medical device industry , a strong attention to detail, and a commitment to maintaining accurate and traceable measurement systems. Key Responsibilities Perform calibration and verification of measurement and test equipment used in manufacturing, inspection, and laboratory environments. Calibrate instruments such as dimensional gauges, pressure gauges, temperature sensors, torque devices, electrical instruments, and other precision equipment. Maintain calibration records, certificates, and documentation in accordance with internal procedures and

ISO 13485

quality system requirements . Ensure measurement traceability to recognized standards (e.g., NIST or equivalent). Troubleshoot and perform minor repairs or adjustments on instruments and equipment as needed. Support investigations for out-of-tolerance equipment and assist with root cause analysis and corrective actions. Coordinate calibration schedules and maintain equipment status within the calibration management system. (GAGEpak) Assist with internal audits, external audits, and regulatory inspections by providing calibration documentation. Collaborate with engineering, manufacturing, and quality teams to ensure measurement systems support product quality and compliance. Follow all company safety policies and quality procedures. Required Qualifications 3-5 years of experience in calibration or metrology , preferably within the medical device industry or another regulated manufacturing environment. Associate's degree or technical certification in electronics, instrumentation, engineering technology, metrology, or a related field (or equivalent experience). Experience calibrating instruments across multiple measurement disciplines such as electrical, dimensional, pressure, temperature, or torque. Familiarity with

ISO 13485

quality systems and regulated manufacturing environments . Experience with calibration management software or CMMS systems. Ability to read technical drawings, specifications, and calibration procedures. Strong troubleshooting, documentation, and organizational skills. Preferred Qualifications Experience supporting medical device manufacturing operations . Knowledge of measurement uncertainty and measurement system analysis (MSA). Professional certification such as ASQ Certified Calibration Technician (CCT) . Experience supporting regulatory audits or quality system inspections. What We Offer Competitive salary and benefits package Opportunities for professional growth and certification Collaborative and quality-driven work environment The opportunity to support the development of life-changing medical devices

Work Location:

In person