What are the responsibilities and job description for the Sr. Complaint Handling Unit Specialist position at Quest Diagnostics?
The Sr. Complaint Handling Unit Specialist conducts complaint handling activities associated with product complaints including managing end-to-end process of customer complaints, medical device reports (MDRs), maintenance of complaint files, risk management files, and responses to customers.
Responsibilities
- Adhere to procedures to ensure timely and accurate receipt, logging, analysis and response to customer complaints. Reviews all customer complaints for validity and assures complaints are processed in compliance with policies and procedures.
- Manage day-to-day complaint assignment; support management in day-to-day operations in a fast-paced work environment
- Assign proper coding of complaints and reportable events
- Evaluates event(s) to determine if it qualifies as a complaint and requires a product investigation.
- Assesses complaint information provided, gather any missing information for complainant file, and escalates complaint for corrective action as needed.
- Generates MDR reports in accordance with Quest procedures and applicable regulations / standards.
- Reviews potential reportable events to determine if regulatory filings are required.
- Perform, monitor, and communicate significant complaint trends, adverse events and other pertinent reports
- Partners with other quality professionals and cross-functional teams to address recurring issues identified throughout the organization.
- Completes product complaint investigations and risk assessment activities with applicable subject matter experts.
- Manages customer relationship and expectations during course of complaint investigation and resolution process.
- Ensures compliance with all federal and international regulations / standards.
- Identify and implement appropriate corrective actions based on complaint analysis to prevent recurrence of issues.
- Monitor the effectiveness of corrective actions and adjust as needed.
- Conduct complaint risk assessment and generate / maintain risk management files.
Required Work Experience :
Physical and Mental Requirements :
Knowledge :
Skills :
Education
Bachelor’s Degree (Required)
