QA Engineering Technician 2
Core
Quality technician ensuring compliance and quality of manufacturing processes for continuous glucose monitoring devices.
Role type
Manufacturing quality technician
Builds
Medical devices (CGM systems)
Domain
Medical device manufacturing
Required skills
inspection, nonconformance event processing, validation protocol execution, audit support, regulatory compliance (GMP, ISO), process improvement, data collection, engineering drawing interpretation
Preferred skills
medical device experience, FDA 21 CFR 820 knowledge, ISO 13485 knowledge, Six Sigma knowledge
Technologies
Microsoft Office
Responsibilities
Process change order and nonconformance event handling, conduct manufacturing inspections from receiving to release, support production line presence, maintain quality assurance protocols, perform line audits, implement corrective actions, identify process improvement opportunities
Seniority
Mid-level, hands-on IC