QE Complaints
Core
Lead quality engineering functions to analyze, resolve, and eliminate customer complaints in medical device manufacturing.
Role type
Quality Engineering Manager (Complaints)
Builds
Corrective action plans, process controls, and inspection mechanisms for medical devices
Domain
Medical Technology / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
manufacturing process knowledge, process monitoring and adjustment, process improvement, corrective action planning, regulatory compliance (federal regulations, GMP, GDP), audit assistance, safety rule enforcement, complaint trend analysis, leadership in issue resolution
Preferred skills
medical device manufacturing industry experience, high-performing team collaboration
Technologies
GMP, GDP, federal regulations for medical devices
Responsibilities
Monitor and analyze customer complaints and trends, develop corrective action plans, coordinate with Process Engineering and Production to establish controls, lead efforts to reduce and eliminate complaints, ensure regulatory compliance and train manufacturing units, assist in internal and external audits, promote plant safety
Seniority
Manager, direct influence on product costs and expenditures