Senior Quality Technician – Calibration Lead (9/80)

THE ALFRED E MANN FOUNDATION FOR SCIENTIFIC R; Santa Clarita (CA); On-site; USD 62,000 - 69,000; Full time

Benefits offered by this job

9/80 schedule

26 long weekends/year

Collaborative teams

Job summary

huMannity Medtec, based in Santa Clarita, CA, is seeking a Senior Quality Technician to oversee calibration activities and DHR reviews, ensuring compliance with FDA QSRs, ISO 13485, and internal procedures. This role supports multiple teams in maintaining equipment traceability and compliant product release documentation.

The Senior Quality Technician will manage calibration vendors, coordinate maintenance, and perform detailed DHR reviews to ensure quality and regulatory readiness prior to

Qualifications

• High school diploma or equivalent required.
• Associate degree in Engineering Technology, Quality, Manufacturing, or related technical field preferred.
• 6+ years of experience in a regulated manufacturing environment (medical device preferred).
• Experience managing calibration systems and working with third-party calibration vendors.
• Familiarity with ISO 13485 requirements related to monitoring and measuring equipment and DHR requirements.
• Experience with inspection tools (calipers, micrometers, height gauges, torque testers, etc.) preferred.

Responsibilities

• Own and maintain the calibration master list and calibration system.
• Schedule, track, and coordinate calibration activities for all equipment.
• Review calibration certificates for accuracy and compliance.
• Maintain calibration records within the eQMS.
• Coordinate calibration vendors and service schedules.
• Ensure equipment labeling and calibration status identification.
• Support audit readiness and manufacturing documentation compliance.
• Review Device History Records (DHRs) for completeness and accuracy.
• Escalate discrepancies and support resolution activities.
• Coordinate with cross-functional teams to keep production ready.

Skills

Quality control

Regulatory compliance

Calibration

DHR

Electrical equipment

Education

High school diploma

Associate degree in Engineering Technology

Tools

eQMS

GMP/ISO standards

Job description

huMannity Medtec, based in Santa Clarita, CA, is seeking a Senior Quality Technician to oversee calibration activities and DHR reviews, ensuring compliance with FDA QSRs, ISO 13485, and internal procedures. This role supports multiple teams in maintaining equipment traceability and compliant product release documentation.

The Senior Quality Technician will manage calibration vendors, coordinate maintenance, and perform detailed DHR reviews to ensure quality and regulatory readiness prior to