Senior Quality/Calibration Technician
Listed on 2026-09-21
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering, Production QC/QA, Quality Control - QC Analysts/Managers
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Santa Clarita, CA, US
Salary Range: $30.00 To $33.00 Hourly
Build a career that makes an impact.
At hu Mannity 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 hu Mannity 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 SummaryThe 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 / ComplianceSupports 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.
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.
- High school diploma or equivalent required.
- Associate degree in Engineering Technology, Quality, Manufacturing, or related technical field preferred.
- 6+ years of…
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