This position is responsible to interface with medical personnel at hospitals, clinics and other medical facilities to obtain and document details of product complaints. Responsibilities include: receiving calls directly from customers or sales reps, obtaining detailed information concerning how the alleged product failure occurred, determining if MDR or Vigilance reporting is required, and filing the necessary reports. This position may also prepare Health Hazard Evaluations and provide clinical input into investigations to support decisions involving potential field actions.
Essential Duties and Responsibilities
Interfaces with hospitals, clinics, physicians and medical personnel to investigate details of product complaints.
Becomes familiar with the Mandatory Medical Device Reporting Requirements (21 CFR 803) and the European Medical Devices Directive (93/4/EEC) for reporting adverse events.
Develops an understanding of the use of AngioDynamics products in order to more effectively investigate failures.
Provides input into risk documents, such as assisting in developing or updating process or design FMEAs.
Provides training to manufacturing and quality personnel relating to product complaints originating in the production processes.
Assessment of complaints for reportability.
May perform other duties as assigned
Manages in order to ensure compliance with all relevant regulatory/legal requirements
QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES
Individual Contributor - Build Quality into all aspects of their work by maintaining compliance to all quality requirements