Equipment Calibration and Qualification Technician

Job Description

Job Description

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.

Preferred Education and Training :

Preferred but not required :

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 :

Schedule : Monday to Friday

Salary

$55,000 - $85,000 per year

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