Quality Calibration Technician

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.

Preferred Qualificationsnice to have

• 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.

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.

• Perform other duties and projects as assigned.