Quality Control Technician

At huMannity Medtec, you don’t just build a career—you help change lives. As a nonprofit medical research and development organization with a nearly 40-year legacy of innovation, we pioneer life‑enhancing technologies for patients with unmet healthcare needs, turning bold ideas into real-world solutions through collaboration across engineering, science, and clinical expertise. Here, curiosity is encouraged, challenges are meaningful, and every project has the potential to make a lasting human impact—because improving lives isn’t just our mission, it’s what we do every day.Position SummaryThe 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 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.ResponsibilitiesQuality / ComplianceSupports quality system compliance activities related to calibration control, manufacturing documentation review, traceability, audit readiness, and regulated quality operations within a medical device manufacturing environment.Manufacturing / OperationsSupports manufacturing operations through equipment calibration coordination, DHR review activities, and product release support to ensure compliance with production and regulatory requirements.Minimum Job RequirementsEducation and ExperienceHigh School diploma or equivalent requiredAssociate degree in Engineering Technology, Quality, Manufacturing, or related technical field preferred3+ 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.Preferred QualificationsExperience working in a medical device or regulated manufacturing environmentFamiliarity with eQMS systemsExposure to audit support activities and regulated quality systemsSkillsStrong organizational and documentation skillsAbility to review records for completeness and accuracyEffective communication and cross-functional collaboration skillsAbility to manage multiple priorities and maintain attention to detailAbility to follow established procedures and escalate discrepancies appropriatelyBasic problem-solving and coordination skillsSite9/80 Schedule