The Complaint Analyst will be a member of the Global Product Support Team to maintain the company's incident reporting (Complaint Handling) system and review of world-wide complaint data. This person will help maintain procedures and policies required to intake, review and approve complaints, while maintaining compliance with applicable Quality System requirements and FDA regulations.
- Maintain and Prepare SOPs, work instructions and workflows for the complaint management system.
- Responsible for ad hoc special projects related to the complaint handling process.
- Identify key parameters affecting complaint closure efficiency
- Review the documentation and preliminary Technical Support investigation of all complaints
- Assure timely completion and database input of complaint investigations and records.
- Follow up with internal and external sources as necessary to ensure complete documentation of complaint related information.
- Notify management of situations that may require to initiate product investigation
- Update complaints database for tracking of complaints.
- Participate in weekly meetings with different tiered Support teams providing summaries/updates of recent complaints
- Initiate, prepare, and distribute reports related to incomplete or incorrect complaint documentation. Provide guidance/assistance to associates and specialists as needed.
- Perform final review/closeout of complaints as necessary.
- Work with regional Technical Support managers and provide reports/data for complaint intake
- Identify key parameters leading to delays that affect complaint closure efficiency
- Track world-wide intake and complaint closure rates
- Author, edit, and curate Knowledge Base content for Technical Support groups