Complaints Quality Engineer II - PMS
Core
Investigate complex manufacturing product quality and compliance issues, perform root cause analysis, and prepare technical investigation reports for medical devices.
Role type
Quality Engineer (Medical Devices)
Builds
Technical investigation reports and risk assessments for transcatheter heart valve devices
Domain
Medical devices / Cardiovascular
Required skills
root cause analysis, complaint investigation, CAPA management, risk assessment, data analysis, documentation, engineering principles
Preferred skills
medical device regulation experience, lab environment familiarity, statistical techniques, risk management
Technologies
calipers, micrometers, pressure gages, leak testing equipment
Responsibilities
Investigate field-reported quality and compliance issues, analyze results to determine root cause, support regulatory requests with risk analysis, assess events against risk documentation, participate in Product Risk Assessments and CAPAs, report key complaint metrics
Seniority
Mid-level, hands-on IC