- 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 experti

📌 Medical Device Complaint Specialist (Centro)
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📍 Centro