Product Complaint and Support Representative

Fresenius Kabi USA

Product Complaint Representative managing medical-device complaints and regulatory documentation for Fresenius Kabi, a global healthcare company. Supporting customers, quality teams, investigations, returns, and complaint reporting.

Posted 8/12/2026full-timeLake Zurich • Illinois • 🇺🇸 United StatesMid-LevelSenior💰 $50,000 - $60,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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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.

Highest-signal resume keywords

FDA Quality Systems KnowledgeComplaint Management Workflow (gCMW)SAP ExperienceCustomer Service FocusAnalytical Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management SystemsRegulatory ComplianceData AnalysisDocumentation ManagementComplaint InvestigationRisk Project PrioritizationCredit AuthorizationSample Retrieval CoordinationReport GenerationProcess Improvement

Soft Skills

Excellent Communication SkillsOrganizational SkillsProblem-Solving SkillsInterpersonal SkillsFlexibility

Tools & Technologies

SAPMicrosoft WordMicrosoft Excel

Industry Keywords

Medical Device Reporting21 CFR 80321 CFR 82021 CFR 211Part 11 CompliancePost Market Quality AssuranceCustomer Feedback Management

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

Medical coverage
Dental coverage
Vision coverage
Life insurance
Disability insurance
401K with company contribution
Wellness program
Comprehensive benefits and programs supporting employee health and wellbeing