What are the responsibilities and job description for the Complaint Specialist position at Helpmates?
Evaluates event(s) to determine if it qualifies as a complaint.
• Assesses complaint information provided, gathers any missing information for complainant file and escalates complaint to appropriate parties as needed.
• Reviews potential reportable events to determine if regulatory filings are required.
• Ensures compliance with all federal and international regulations applicable to manufactured medical devices.
• Documents and completes complaints promptly.
• Stays current with knowledge of and adheres to Quality systems
• Interacts professionally with all organizational levels.
• Manages competing priorities in a fast-paced environment.
• Generates and submits medical device event reports to appropriate authorities and government agencies as required by applicable laws and regulations.
• Processes samples for decontamination if necessary.
• Prepares complaint files for closure.
• Leads weekly internal department meetings.
• Performs complaints report analysis.
• Prepares and submits final customer correspondence as required.
• Supports preparations for audits.
• Reviews and prepares complaint files for closure.
• Reviews/edits the work product of CSI
Salary : $30
