Quality Calibration Technician

Position Summary

The Equipment Quality & Controls Technician is responsible for the hands-on calibration, maintenance, control, and compliance of inspection, test, and manufacturing equipment used throughout TransMedics' operations. This role ensures equipment remains within established specifications and regulatory requirements through the execution of calibration activities, preventive maintenance, equipment troubleshooting, vendor coordination, and documentation management.

Essential Responsibilities

Equipment Calibration & Maintenance

• Perform in-house calibrations and verification activities on inspection, monitoring, measurement, and test equipment.
• Execute routine preventative maintenance activities on production, engineering, and facility related equipment.
• Troubleshoot basic equipment issues and coordinate repairs with equipment owners, Engineering, Facilities, and external vendors.
• Ensure equipment remains calibrated and maintained within established frequencies and specifications.
• Maintain proper equipment identification, calibration status labeling, and traceability.

Calibration Program Administration

• Maintain the electronic calibration and maintenance management system.
• Create, issue, and maintain equipment asset records, calibration histories, and maintenance documentation.
• Review, approve, and archive calibration and preventative maintenance records.
• Record calibration data and results in designated software systems.
• Generate and distribute calibration schedules, PM schedules, and overdue equipment reports.
• Establish and maintain calibration files and equipment documentation in accordance with quality system requirements.

Vendor & Cross-Functional Coordination

• Schedule and coordinate on-site and off-site calibration and maintenance activities with approved vendors.
• Collaborate with equipment owners, Facilities, Manufacturing, Engineering, and Quality personnel to ensure minimal disruption to operations.
• Monitor vendor performance and confirm timely completion of calibration and maintenance activities.

Compliance & Quality Support

• Ensure compliance with FDA, ISO 13485, and internal quality system requirements.
• Investigate out-of-tolerance (OOT) calibration events and support root cause investigations and corrective actions.
• Assist with equipment qualification, validation, and change control activities as required.
• Support internal audits, external audits, and regulatory inspections involving equipment management records.
• Maintain data integrity and documentation accuracy in accordance with Good Documentation Practices (GDP).

Continuous Improvement

• Identify opportunities to improve calibration processes, preventive maintenance programs, and equipment reliability.
• Participate in equipment lifecycle management initiatives and calibration program optimization efforts.
• Support implementation and continuous improvement of electronic calibration management systems.

Minimum Qualifications

• 2+ years of experience performing equipment calibration, metrology, preventative maintenance, or equipment management activities.
• Working knowledge of metrology principles and precision measurement techniques.
• Experience using calibration management or CMMS software systems.
• Experience working in a regulated manufacturing environment.

Preferred Qualifications

• 3+ years of experience in the medical device, biotechnology, pharmaceutical, or other FDA-regulated industry.
• Knowledge of FDA 21 CFR Part 820, Part 211, and ISO 13485 requirements.
• Experience investigating and documenting Out-of-Tolerance (OOT) calibration events.
• Familiarity with controlled environments, cleanroom operations, and ESD controls.
• Experience supporting equipment qualification and validation activities.
• Strong proficiency with Microsoft Office Suite and electronic quality management systems.
• Understanding of basic statistical concepts including averages, standard deviation, and measurement uncertainty.

Knowledge, Skills & Abilities

• Strong hands-on mechanical and technical aptitude.
• Ability to use calibration standards, measurement instruments, and precision test equipment.
• Strong analytical and troubleshooting skills.
• Excellent organizational skills with the ability to manage multiple priorities simultaneously.
• Strong verbal and written communication skills.
• Ability to work independently and collaborate effectively within cross-functional teams.
• Detail-oriented with a commitment to quality, compliance, and data integrity.

Physical Requirements

• Ability to sit, stand, walk, bend, squat, kneel, reach, and lift equipment as required.
• Ability to safely move equipment and calibration standards weighing up to 30 pounds.
• Fine motor skills necessary to operate measurement devices, hand tools, and computer systems.
• Ability to work in laboratory, manufacturing, warehouse, and cleanroom environments.
• Ability to distinguish colors, read instrument displays, and interpret technical documentation.
• Ability to follow all applicable safety and environmental procedures.