Quality Control Technician
huMannity Medtec · Santa Clarita, CA · 3 wk ago
Quality AssuranceFull-time
Responsibilities
- Supports quality system compliance activities related to calibration control, manufacturing documentation review, traceability, audit readiness, and regulated quality operations.
- 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.
Requirements
- 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.
- Equivalent combination of education and relevant experience may be considered.
- 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.
- Basic understanding of validated production equipment is a plus.
Qualifications
- Education and Experience:
- 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.
- Equivalent combination of education and relevant experience may be considered.
- Experience:
- 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.
- Basic understanding of validated production equipment is a plus.