Complaint Handling

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Function:

Role:

Desired Skills:

• Evaluates incoming complaint information and maintains the record in the electronic database.
• Perform follow up activities to obtain additional information. Use and maintain database(s), provide analysis and trending data all on complaints.
• Determines Reportability of complaints to Government Agencies.
• Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.
• Writes investigation summaries based on technical product analysis information provided;
• Ensures record documentation is maintained in a constant state of audit readiness per internal policies.
• Liaison with groups who perform additional investigation and who prepare written record of investigation.
• Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.
• Ability to understand the functionality / intended use of complex medical devices.