QE Engineer II质量工程师
Core
Organize and develop on-site quality management strategies, handle non-conformance disposal, and manage quality transfer activities for production.
Role type
Quality Engineer II (Production Quality)
Builds
Dialysis products (filters, sterile preparations, blood tubing, dialysis machines) and plastic/extrusion components
Domain
Medical device manufacturing (dialysis)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality management strategy development, non-conformance investigation and root cause analysis, quality transfer from R&D to production, change evaluation and tracking, First Article Inspection (FAI), incoming inspection, post-market complaint investigation, quality risk management, internal audit execution
Preferred skills
Knowledge of active medical device production and process quality control
Technologies
None explicitly stated
Responsibilities
Organize on-site quality management methods and strategies, dispose of non-conformances (discovery, investigation, rectification), transfer quality standards and testing methods from product/process development, evaluate production-related changes, conduct FAI and incoming inspections, investigate post-market feedback/complaints, participate in quality risk management, execute internal audits
Seniority
Mid-level, hands-on IC
