Quality Calibration Technician

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

Job Description: 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's 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. The ideal candidate possesses strong knowledge, experience with calibration systems, and a solid understanding of FDA‑regulated manufacturing environments. This position works closely with Manufacturing, Engineering, Facilities, and external service providers to maintain a compliant and effective Equipment Quality & Controls management program.

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.

Additional Responsibilities