Complaint Analyst (w/m/d)
Core
Investigate customer complaints for active medical devices, coordinate root cause analysis with production and suppliers, and manage corrective and preventive actions (CAPAs).
Role type
Complaint Analyst (Medical Devices)
Builds
Corrective and preventive action plans (CAPAs) and quality statistics for medical device manufacturers.
Domain
Medical Devices / Quality Management
Required skills
Medical device complaint investigation, CAPA management, root cause analysis, ISO 13485/21 CFR 820 QSR knowledge, CAQ system usage, data preparation for quality meetings.
Preferred skills
None stated.
Technologies
CAQ systems, MS Office.
Responsibilities
Investigate national and international customer complaints for active medical devices; Identify investigation tasks and assign them to responsible departments; Coordinate execution of investigations and root cause analyses with production, development, and suppliers; Define and track Immediate Actions, Corrections, and CAPAs; Manage correspondence between the Complaint Investigation Unit and service areas; Moderate meetings to align on complaint handling procedures; Prepare data and statistics for quality review meetings.
Seniority
Mid-level (2+ years experience)