Quality Technician 2 Back End Days
Core
Hands-on quality support within a regulated medical device manufacturing environment, ensuring compliance with internal procedures, GMP, and regulatory standards.
Role type
Quality Technician (Medical Device Manufacturing)
Builds
Continuous Glucose Monitoring (CGM) devices and related biosensing technology
Domain
Medical Device Manufacturing / Biosensing Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, nonconformance investigation, CAPA execution, audit support, data collection and analysis, inspection execution, regulatory knowledge (FDA/ISO), documentation management, cross-functional collaboration
Preferred skills
Change order processing, MES/ERP/QMS system proficiency, process improvement initiatives, training and mentoring
Technologies
Microsoft Office, MES, ERP, QMS applications
Responsibilities
Process and analyze nonconformance events, support internal and external audits, review and manage quality documentation, perform routine line audits, assist with inspection methods and specifications, update quality assurance procedures, identify opportunities for process improvement
Seniority
Mid-level, hands-on IC