Product Complaint and Support Representative

• Manage workflow for all quality-related internal and external inquiries
• Evaluate initial complaints for investigation needs within the Global Complaint Management Workflow (gCMW)
• Capture complaint information and required documentation before closure
• Follow up with customers to collect required information
• Coordinate sample retrieval, return tracking, and follow-ups
• Coordinate product returns with Post Market Quality Assurance and Customer Service
• Evaluate and authorize customer credit when applicable
• Provide customers with complaint receipts, status updates, and final evaluation letters
• Attend product-specific monthly Product Review Meetings and report updates
• Escalate customer and product complaints to the internal commercial team
• Process commercial team requests for data, complaint details, and credit reports
• Provide reports to commercial team members
• Participate in customer meetings
• Escalate customer feedback regarding quality processes
• Collaborate with Post Market Quality Assurance and Quality Engineers on trends, investigations, and process improvements
• Assist with investigations of high-risk complaints
• Ensure compliance with Health, Safety, Environment, Energy, and Quality Management Systems

• Bachelor Degree preferred
• SAP experience preferred
• 1–3 years of customer-facing and/or quality-related experience preferred
• Knowledge of FDA Quality Systems and Medical Device Reporting regulations (21 CFR 803, 820, 211, and Part 11) a plus
• Ability to prioritize multiple risk projects for regulatory and SOP compliance
• Excellent written and verbal communication and organizational skills
• Strong problem-solving and analytical skills
• Flexibility to work on new products and assignments
• Strong computer skills, including Word and Excel
• Strong interpersonal skills and ability to work with cross-functional teams
• Self-motivated and quick learner
• Exceptional customer-service focus
• Must effectively speak, read, write, and understand English
• Must be authorized to work for any employer in the United States; visa sponsorship unavailable

Demonstrates expertise in managing quality-related inquiries and compliance with FDA Quality Systems and Medical Device Reporting regulations. Proficient in customer service, complaint management, and collaboration with cross-functional teams to drive process improvements.

• FDA Quality Systems Knowledge
• Complaint Management Workflow (gCMW)
• SAP Experience
• Customer Service Focus
• Analytical Skills

• Quality Management Systems
• Regulatory Compliance
• Data Analysis
• Documentation Management
• Complaint Investigation
• Risk Project Prioritization
• Credit Authorization
• Sample Retrieval Coordination
• Report Generation
• Process Improvement

• Excellent Communication Skills
• Organizational Skills
• Problem-Solving Skills
• Interpersonal Skills
• Flexibility

• Medical Device Reporting
• 21 CFR 803
• 21 CFR 820
• 21 CFR 211
• Part 11 Compliance
• Post Market Quality Assurance
• Customer Feedback Management

• SAP
• Microsoft Word
• Microsoft Excel