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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 SummaryÂ
The 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.
Responsibilities
Quality / Compliance
Supports 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 / Operations
Supports manufacturing operations through equipment calibration coordination, DHR review activities, and product release support to ensure compliance with production and regulatory requirements.
Minimum Job Requirements
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 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 Qualifications
- Experience working in a medical device or regulated manufacturing environment
- Familiarity with eQMS systems
- Exposure to audit support activities and regulated quality systems
Skills
- Strong organizational and documentation skills
- Ability to review records for completeness and accuracy
- Effective communication and cross-functional collaboration skills
- Ability to manage multiple priorities and maintain attention to detail
- Ability to follow established procedures and escalate discrepancies appropriately
- Basic problem-solving and coordination skills
#LI-On-Site
9/80 Schedule
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