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
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📌 Medical Device Complaint Specialist (Jalisco)
🏢 Jobtailor
📍 Jalisco