Quality Complaint & Customer Support Specialist

Fresenius Kabi; Lake Zurich (IL); On-site; USD 50,000 - 60,000; Full time

Job summary

Fresenius Kabi in the United States is seeking a customer-facing quality specialist to be the first point of contact for product quality defects in MedTech within Region North America.

You will manage inquiries, collect documentation, coordinate sample returns, and provide timely updates to customers and the sales teams, ensuring compliance with FDA Quality Systems and global procedures.

Qualifications

• Bachelor degree preferred and knowledge of FDA QSR and MDR a plus.
• 1-3 years of customer-facing and/or quality-related experience preferred.
• Strong written/verbal communication and organizational skills.
• Ability to prioritize multiple risk projects to ensure regulatory compliance.

Responsibilities

• Manage workflow for all quality related inquiries (internal and external).
• Capture all complaint information in the Global Complaint Management Workflow (gCMW).
• Coordinate sample retrieval, tracking and return follow ups.
• Coordinate quality related product returns with Post Market Quality Assurance and Customer Service.
• Provide timely response to customers with status updates and final evaluation letters.

Skills

Customer facing

Quality management

Regulatory compliance

Cross-functional collaboration

Communication

Problem solving

Documentation

Education

Bachelor's degree

Tools

SAP

Job description

Fresenius Kabi in the United States is seeking a customer-facing quality specialist to be the first point of contact for product quality defects in MedTech within Region North America.

You will manage inquiries, collect documentation, coordinate sample returns, and provide timely updates to customers and the sales teams, ensuring compliance with FDA Quality Systems and global procedures.