Analyze and process complaints uniformly and timely for proper complaint coding and accurate assessment. Assess vigilance reportability for moderate-risk complaints using system-based decision trees. Perform data entry and prepare reports and graphs for special projects, complaints, and lot qualification. Maintain accurate documentation and files for special projects, complaints, and lot qualification. Review and analyze lot documentation and device history records to identify anomalies related to reported product failures. Process feedback letters and communicate with product support managers for reporting sites. Perform basic product review and failure analysis. Support investigations and reviews of potential adverse events. Support database development and reporting capabilities for complaint and reliability department needs. Assist with gathering information and data for FDA, ISO, third-party, and internal audits. Lead continuous-improvement projects for the complaint-handling function. Perform other duties as required. Requirements High school diploma or technical or scientific discipline; and/or equivalent combination of education and experience. Complaint handling experience preferred. Minimum of 1-2 years’ experience in data management, record keeping, and troubleshooting in the Medical Device field, or other transferable experience related to organization, technical aptitude and data management.



Effective verbal and technical writing skills; ability to communicate at multiple levels of an organization. Ability to organize and judge priorities. Ability to generate and maintain organized and accurate records. PC skills, including word processing, spreadsheets, and databases. Ability to work effectively in a high-stress, high-energy environment. Ability to make decisions quickly based on vague or imperfect information and evaluate when clarification and direction are necessary. Core Competencies Demonstrates expertise in complaint handling, data management, and documentation within the Medical Device field, with strong capabilities in technical writing and effective communication across organizational levels. Highest-signal resume keywords Complaint Handling Experience Data Management Technical Writing Skills Medical Device Knowledge Record Keeping ATS Optimization Keywords Hard Skills Data Entry Failure Analysis Report Preparation Documentation Management Vigilance Reportability Assessment Anomaly Identification Database Development Troubleshooting Special Project Support Continuous Improvement Soft Skills Effective Communication Organizational Skills Decision-Making Prioritization Ability to Work Under Stress Industry Keywords FDA Compliance ISO Standards Adverse Event Reporting Medical Device Field Internal Audits Tools & Technologies Word Processing Software Spreadsheets #J-18808-Ljbffr

📌 Medical device complaint specialist (Guadalajara)
🏢 Jobtailor
📍 Guadalajara