Senior Quality Technician: Calibration & Compliance Lead

huMannity Medtec; Santa Clarita (CA); On-site; USD 41,000 - 45,000; Full time

Benefits offered by this job

9/80 schedule with every other Friday"

Job summary

huMannity Medtec in Santa Clarita, CA is seeking a Senior Quality Technician to manage calibration activities, DHR reviews, and manufacturing documentation in compliance with FDA QSR, ISO 13485, and internal procedures.

This role leads calibration program, coordinates vendors, performs detailed DHR reviews, and supports audits, traceability, and product release; requires strong attention to detail and cross-functional collaboration.

Qualifications

• High school diploma or equivalent required.
• Associate degree preferred.
• 6+ years in regulated manufacturing (medical device preferred).
• Experience with calibration systems and vendors.
• Familiarity with ISO 13485 and DHR requirements.

Responsibilities

• Own 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 in the eQMS.
• Support audits and management reviews.
• Coordinate with Facilities, Manufacturing, Engineering, and Quality teams.
• Review DHRs for completeness and compliance prior to product release.
• Escalate discrepancies and support resolution.

Skills

Calibration coordination

Documentation review

Regulatory compliance

Attention to detail

Cross-functional collaboration

Problem solving

Communication skills

Time management

Independent work

Education

High school diploma or equivalent

Associate degree in Engineering/Quality/Manufacturing

Tools

Calibration system (eQMS)

Third-party calibration vendors

Inspection tools (calipers, micrometers)

Audit documentation tools

Job description

huMannity Medtec in Santa Clarita, CA is seeking a Senior Quality Technician to manage calibration activities, DHR reviews, and manufacturing documentation in compliance with FDA QSR, ISO 13485, and internal procedures.

This role leads calibration program, coordinates vendors, performs detailed DHR reviews, and supports audits, traceability, and product release; requires strong attention to detail and cross-functional collaboration.