Senior Quality/Calibration Technician

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Santa Clarita, CA, US

Salary Range: $30.00 To $33.00 Hourly

Build a career that makes an impact.

At huMannity Medtec, you don’t just build a career, you help change lives.

For over 40 years, we have been advancing life-enhancing medical technologies that address unmet healthcare needs. Our teams bring together engineering, science, and clinical expertise to transform bold ideas into solutions that can make a difference for patients around the world.

We believe meaningful work and a balanced life go hand in hand. That is why we offer a 9/80 schedule, giving our employees every other Friday off. That means 26 extra long weekends each year to recharge, spend time with family and friends, pursue hobbies, or simply enjoy more balance outside of work.

Why huMannity Medtec?
Mission-driven work that impacts lives
A 9/80 schedule with every other Friday off (26 long weekends a year!)
Collaborative teams solving complex challenges
Opportunities to learn, grow, and make an impact
Weekly team traditions, monthly lunches, and quarterly events that bring us together

Here, your work has purpose. Your ideas are valued. Your curiosity is encouraged.

Ready to be part of something meaningful?

Position Summary

The Senior Quality Technician ensures calibration activities, Device History Record (DHR) reviews, and manufacturing documentation comply with FDA Quality System Regulations, ISO 13485 requirements, and internal quality procedures. This role serves as the subject matter expert for calibration activities and supports manufacturing, engineering, facilities, and quality teams in maintaining equipment traceability, audit readiness, and compliant product release documentation.

The Senior Quality Technician owns and maintains the site-wide calibration program, coordinates calibration vendors and maintenance activities, supports impact assessments, and performs detailed DHR reviews to ensure products meet all quality and regulatory requirements prior to release.

Responsibilities

Quality / Compliance

Supports quality system compliance activities related to calibration control, manufacturing documentation review, traceability, audit readiness, product release, and regulated quality operations within a medical device manufacturing environment.

Responsibilities include:

• Own and maintain the company's calibration master list and calibration system.
• Schedule, track, and coordinate calibration activities for all required equipment.
• Review calibration certificates for accuracy, tolerance requirements, and compliance standards.
• Ensure proper equipment labeling and calibration status identification.
• Maintain calibration records and supporting documentation within the eQMS.
• Monitor calibration metrics and support management review activities.
• Manage out-of-tolerance events and support impact assessments.
• Serve as the calibration subject matter expert during internal and external audits.
• Support continuous improvement initiatives related to measurement systems and compliance.
• Review Device History Records (DHRs) for completeness, accuracy, and compliance prior to product release.
• Verify manufacturing records, inspection results, traceability requirements, and documentation approvals.
• Escalate discrepancies, place lots on hold when necessary, and support resolution activities.

Manufacturing / Operations

Supports manufacturing operations through calibration coordination, maintenance-related quality activities, DHR review, and product release support to ensure compliance with production and regulatory requirements.

Responsibilities include:

• Coordinate calibration vendors, service schedules, equipment pickup, and return activities.
• Establish calibration requirements and intervals for new equipment.
• Partner with Facilities, Manufacturing, Engineering, and Quality teams to ensure equipment remains compliant and production-ready.
• Support maintenance and repair activities requiring recalibration assessments.
• Maintain documentation linkage between maintenance activities and calibration records.
• Assist with equipment status control and segregation of nonconforming equipment.
• Support audit readiness and manufacturing documentation compliance across operations.

Education and Experience

• 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) required. Equivalent combinations of education and relevant experience may be considered.
• Experience managing calibration systems and working with third-party calibration vendors required.
• Familiarity with ISO 13485 requirements related to monitoring and measuring equipment and DHR requirements 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.
• Basic understanding of validated production equipment is a plus.

Preferred Qualifications

• Experience working in a medical device or other highly regulated manufacturing environment.
• Experience serving as a calibration lead, owner, or subject matter expert.
• Familiarity with eQMS systems and electronic documentation management.
• Experience supporting audits and maintaining audit-ready calibration records.
• Experience reviewing manufacturing documentation and Device History Records.

Skills

• Strong organizational and documentation skills.
• Ability to review technical and manufacturing records for completeness and accuracy.
• Strong attention to detail and regulatory compliance requirements.
• Effective communication and cross-functional collaboration skills.
• Ability to manage multiple priorities and coordinate activities across departments and vendors.
• Ability to identify, escalation, and help resolve quality compliance issues.
• Strong problem-solving and analytical skills.
• Ability to work independently while supporting cross-functional teams.