Quality Technician 2 Back End Days
Core
Execute routine quality activities, monitor in-process controls, and support investigations in a regulated medical device manufacturing environment.
Role type
Quality Technician (Medical Device Manufacturing)
Builds
CGM devices and other medical biosensing products
Domain
Medical Device Manufacturing / Biosensing
Required skills
GMP compliance, CAPA investigation, nonconformance analysis, audit support, inspection data collection, regulatory standards knowledge (ISO/FDA), documentation management, cross-functional collaboration
Preferred skills
Six Sigma, MES/ERP/QMS system experience, global project experience, mentoring junior staff
Technologies
Microsoft Office, MES, ERP, QMS applications
Responsibilities
Process Change Orders and Nonconformance Events (NCEs), collect manufacturing data for investigations, perform routine line audits, update quality procedures, verify compliance with GMP/GLP/ISO, support disposition of nonconforming materials, identify process improvement opportunities
Seniority
Mid-level, hands-on IC