Please note that this is a 6 months contract position.
Review and analyze assigned to him/her customer complaints; and proper investigate the complaint and contact the customer if necessary.
This individual will evaluate all information from a clinical and technical perspective to ensure appropriate Subject codes, Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.
The Complaints Coding Specialist will ensure proper documentation and closure of each complaint in order to make and document sound regulatory reporting decisions/justifications for worldwide reporting.
The Complaints Coding Specialist will develop, establish, prepare and distribute dashboards and reports to assure complaints are processed and coded in a timely manner.
This individual will develop a thorough understanding of the complaint database.
Additionally, The Complaints Coding Specialist will develop, prepare, and analyze reports for coded complaints on a weekly and monthly basis, as required.
The Complaints Coding Specialist will escalate critical issues for proper disposition as necessary.
Authors Clear, Technical, and Accurate Reports Describing Complaints and Investigations for Compliance Files
Reviews Incoming Complaints and Completes Good-Faith Effort to Collect Additional Information as Required
Independently Completes Medium Complexity Complaint Investigations within Required Timelines (e.g. "Out of the Box" Failure Investigations)
Initiates Company Issue Escalation Process as Required
Investigates and Documents Complaint Trend Analyses
Coordinates Initiation of Company CAPA Process as Required
Makes Significant Contributions to Improvement Initiatives
Contributes to Document Change Orders
Maintains Compliance to Applicable Foreign and Domestic Regulations Governing the Management and
Processing of Medical Device Related Complaints including Protected Health Information (PHI) and Patient Privacy Laws
Performs other duties assigned as needed
Required Minimum Education:
Bachelors Degree or Equivalent - A degree in Science, Engineering, Nursing,Biology, Chemistry or related technical field
Required Years of Related Experience:
2-4 years related experience
Experience in medical device or other FDA regulated industry.
For consideration, please reference job number 2970