Major Duties and Responsibilities: Tasks/Duties/Responsibilities Other Duties: • The Complaints Coding Specialist will 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.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES: • Must possess the basic understanding of engineering fundamentals. • Advanced critical thinking and investigation skills are required. • Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required. Candidate must be able to effectively prioritize and manage multiple activities and responsibilities. • Ability to understand and follow complex written procedures is required. Candidates should be • familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices. • Ability to function in a team environment and deliver on team objectives is required. Ability to influence and drive change is preferred. Prefer project management and/or process mapping experience. • Communication Skills: Strong written and verbal communication skills are required. Must be highly proficient in reading, writing, and speaking the English language. • Technical writing is a routine part of this position. Strong attention to detail is required. • Required Computer Skills: Familiarity with computers and Windows-based PC applications. Ability to learn and manipulate complex computer system applications is required. Ability to type at least 50 words per minute (WPM) is required. Experience with word processor software (e.g. Microsoft Word) and internet browsers (e.g. Internet Explorer) is required. Prefer experience with Siebel Complaint Management System.