Quality Control Technician
$49,920–$54,080 year
On-site · Santa Clarita, California, United States
Job Summary
Quality Technician ensures calibration activities, Device History Record (DHR) reviews, and manufacturing documentation comply with FDA Quality System Regulations, ISO 13485 and internal quality procedures. Serves as the primary point of contact for calibration activities and supports manufacturing, engineering, facilities, and quality teams in maintaining equipment traceability, audit readiness, and compliant product release documentation. Responsibilities include calibration control, manufacturing documentation review, traceability, audit readiness, and regulated quality operations within a medical device manufacturing environment; coordinating equipment calibration, conducting DHR reviews, and supporting product release to ensure regulatory compliance.
Required Qualifications
- High School diploma or equivalent required
- Associate degree in Engineering Technology, Quality, Manufacturing, or related technical field preferred
- 3+ years of experience in a regulated manufacturing environment (medical device preferred) required
- Experience managing calibration systems and working with third-party calibration vendors required
- Familiarity with 21 CFR 820 and/or ISO 13485 requirements related to monitoring and measuring equipment required
- Experience with inspection tools (calipers, micrometers, height gauges, torque testers, pin gauges, thread gauges, etc.) preferred
- Understanding of traceability and tolerance requirements preferred
- Experience with eQMS systems preferred
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