Equipment Calibration and Qualification Technician

Overview

The Equipment Calibration and Qualification Technician performs calibration and qualification of research and manufacturing equipment, ensuring regulatory compliance with FDA’s 21 CFR Part 820 and ISO 13485, and compliance with other standards. Responsibilities include calibrating equipment, executing qualification protocols, maintaining calibration records, coordinating external services, and supporting validation activities. The role requires hands-on work with precision measurement tools, strong attention to detail, regulatory knowledge, and excellent documentation skills. This full-time, on-site position also involves assisting with other Quality Assurance and validation tasks as needed.

Reports to:

Vice President of Quality Assurance & Regulatory Affairs

Duties and Responsibilities:

The Equipment Calibration and Qualification Technician’s responsibilities include:

• Managing all calibration of manufacturing and laboratory equipment, including torque wrenches, pressure gauges, temperature sensors, analytical balances, micrometers, calipers, and other precision measuring instruments.
• Ensuring all calibrated equipment is labeled and that calibration or qualification has not expired.
• Maintaining accurate calibration records, certificates, and documentation in compliance with FDA 21 CFR Part 820, ISO 13485.
• Updating the equipment database with the current qualification and requalification status,and using it to ensure the timely completion of all activities, whether performed internally or externally.
• Providing calibration and qualification status reports and metrics to management and support teams.
• Writing, performing, and documenting equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Preventive Maintenance (PM).
• Supporting validation activities for new equipment, as well as modification or relocation of existing equipment.
• Supporting internal and external audits by providing calibration and qualification documentation, technical expertise, and responses to audit findings related to measurement systems and calibration processes.
• Participating in corrective and preventive action (CAPA) investigations related to calibration and qualification non-conformances, equipment failures, and measurement system issues.
• Following all company policies, procedures, and safety protocols when performing calibration and qualification activities in laboratory, manufacturing, and clean room environments.

Skills and Experience:

The Equipment Calibration and Qualification Technician should use existing skills to perform calibration and qualification procedures, maintain documentation, and ensure regulatory compliance in individual and team projects. The following abilities may assist in completing these tasks.

• Proficient with precision measuring instruments, including micrometers, calipers, torque wrenches, pressure gauges, temperature sensors, analytical balances, and electronic test equipment for calibration activities.
• Strong computer skills, such as proficiency in Microsoft Office Suite for documentation, reporting, and data analysis, as well as experience with database systems for tracking equipment status, maintaining records, and generating reports and certificates.
• Experience with calibration principles, measurement uncertainty concepts, and statistical analysis of measurement data for equipment performance evaluation.
• Understanding of national and international measurement standards (NIST, ISO 17025) and traceability requirements for calibration activities.
• Familiar with medical device manufacturing regulatory requirements, including FDA 21 CFR Part 820, ISO 13485, and Good Manufacturing Practices (GMP).
• Knowledge of equipment qualification processes (IQ/OQ/PQ) and validation documentation requirements in regulated manufacturing environments.
• Experience with metrology equipment maintenance, storage, and handling procedures to ensure measurement accuracy and equipment longevity.
• Ability to read and interpret technical drawings, specifications, calibration procedures, and equipment manuals for various measuring instruments.
• Problem-solving abilities to troubleshoot calibration issues, identify root causes of equipment failures, and recommend corrective actions.
• Highly organized with strong attention to detail and time management skills.
• Excellent written and verbal communication skills for documentation, reporting, and coordination with cross-functional teams.
• Ability to work independently while following established procedures and collaborate effectively with quality, engineering, and manufacturing teams.
• Must be able to lift 50 lbs and work in various environments, including laboratories, manufacturing floors, and clean rooms.

Preferred Education and Training:

• Associate or Bachelor’s Degree in Engineering Technology, Electronics, Instrumentation, Metrology, or related technical field.
• 2+ years' experience in calibration, metrology, or instrumentation, preferably in the medical device, pharmaceutical, or other regulated industry.
• 2+ years of hands-on experience with precision measuring instruments and calibration equipment in a manufacturing or laboratory environment.
• 2+ years of experience with calibration management software and equipment tracking systems.

Preferred but not required:

• ASQ Calibration Technician Certification or equivalent industry certification.
• NCSL International training certificates in calibration and measurement principles.
• Experience with equipment qualification (IQ/OQ/PQ) processes in FDA-regulated manufacturing environments.
• Knowledge of ISO 17025 laboratory accreditation requirements and measurement management systems.
• Equipment-specific manufacturer certifications for calibration of specialized instruments.

Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans' status, or any other characteristic protected by law.

To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State.

Benefits:

• 401(k) Safe Harbor Plan
• Healthcare Insurance: Medical, Dental and Vision
• Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance
• Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave
• Tuition Reimbursement Program
• Performance Bonus
• Flexible Schedule
• Lunches, Snacks, Events

Schedule:
Monday to Friday

Salary
$55,000 - $85,000 per year

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