Quality Engineer 2
Core
Ensuring quality system compliance for commercial logistics and operations in the medical device industry through field inspection, data analytics, and root cause analysis.
Role type
Quality Engineer (Medical Devices)
Builds
Field quality processes, inspection procedures, and corrective actions for medical instruments.
Domain
Medical Devices / Manufacturing Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis (RCA), statistical analysis, visual inspection, dimensional measurement, GMP compliance, FDA QSR knowledge, ISO 13485 knowledge, PFMEA, drawing print reading
Preferred skills
ASQ CQE certification, advanced mathematics, training others on inspection methods
Technologies
PC and computer systems, technical measurement equipment, eFIP data analytics
Responsibilities
Maintain Electronic Field Inspection Procedure (EFIP) architecture and perform advanced troubleshooting, verify and validate requirements for finished products and raw materials, establish and support visual and dimensional inspections per GMPs, perform root cause analysis to correct and prevent recurrence of issues, train others on instrument use and inspection methods
Seniority
Intermediate, hands-on IC