Complaint Quality Engineer II - PMS
Core
Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports for medical devices.
Role type
Quality Engineer (Medical Device)
Builds
Technical investigation reports and compliance documentation for transcatheter heart valves
Domain
Medical device / Cardiovascular / Regulatory compliance
Deliverable
client delivery
Required skills
Root cause analysis, complaint investigation, CAPA management, risk assessment, data analysis, documentation, engineering principles
Preferred skills
Medical device experience, lab environment familiarity, statistical techniques, risk management
Technologies
Calipers, micrometers, pressure gages, leak testing equipment
Responsibilities
Investigate field-reported product failures, support external regulatory requests, assess events against risk documentation, participate in Product Risk Assessments and CAPAs, report key complaint metrics
Seniority
Mid-level, hands-on IC