Precision Calibration Technician - Quality & Compliance

TransMedics, Inc.; Andover (MA); On-site; USD 65,000 - 85,000; Full time

Job summary

TransMedics, Inc. is seeking a Quality Calibration Technician to oversee hands-on calibration, maintenance, control, and documentation of inspection, test, and manufacturing equipment across operations.

The role ensures equipment stays within specifications and FDA/ISO 13485 requirements. You will work with Manufacturing, Engineering, Facilities, and external service providers to manage calibration programs, records, schedules, and nonconformances, contributing to continuous improvement and data

Responsibilities

• 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.
• 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.
• 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.
• 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).
• 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.

Job description

TransMedics, Inc. is seeking a Quality Calibration Technician to oversee hands-on calibration, maintenance, control, and documentation of inspection, test, and manufacturing equipment across operations.

The role ensures equipment stays within specifications and FDA/ISO 13485 requirements. You will work with Manufacturing, Engineering, Facilities, and external service providers to manage calibration programs, records, schedules, and nonconformances, contributing to continuous improvement and data