Responsibilities and Duties:
- To manage the customer complaint handling process in the Quality group.
- Analyze information from customer complaints and report trends, as necessary.
- To assist in the review of customer complaints for adverse events and possible MDR reporting
- To assist in the processing, investigation, and coding of customer complaints and other quality investigations (e.g., Corrective Action Requests, etc.) as needed.
- To assist in the compilation and processing of quality information for the trending, summarizing and reporting of quality indicators for Management Review
- To enter complaint investigation information in the customer complaint database
- Review service records for possible adverse events
- Manage Recalls, as needed
- Computer literacy with commonly used Microsoft Office products
- Excellent attention to detail and organizational skills
- Demonstrated proficiency utilizing computer software used in customer complaint administration, trending and analysis of data, generation of quality indicators, and other quality related activities.
- 4-year degree preferred
- ISO 9001, ISO 13485 and FDA medical device training preferred