Product Complaint and Support Representative

Fresenius Kabi USA

Product Complaint Representative managing MedTech quality complaints for Fresenius Kabi, a global healthcare company. Coordinating investigations, customer communications, product returns, and regulatory documentation.

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 complaints within the MedTech industry, ensuring compliance with FDA regulations and internal SOPs. Strong ability to collaborate with cross-functional teams and provide exceptional customer service while maintaining detailed documentation and reporting.

Highest-signal resume keywords

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management SystemsRegulatory ComplianceData AnalysisDocumentation ManagementComplaint InvestigationProcess ImprovementRisk Project PrioritizationMicrosoft WordMicrosoft Excel

Soft Skills

Excellent Communication SkillsOrganizational SkillsInterpersonal SkillsFlexibilitySelf-Motivation

Industry Keywords

Medical Device Reporting RegulationsPost Market Quality AssuranceCustomer Feedback EscalationProduct Review MeetingsSOP Compliance

About the role

Key responsibilities & impact

Act as the first point of contact for quality-related MedTech product defects in North America
Serve as primary contact and support for customers and the Medical Device Commercial Organization regarding quality-related complaints
Manage workflow for internal and external quality-related inquiries
Evaluate initial complaints for investigation needs within the Global Complaint Management Workflow (gCMW)
Capture complaint information and required documentation in gCMW before closure
Follow up with customers to collect required information under SOPs and regulations
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 monthly Product Review Meetings and report updates to the MedTech Commercial Organization
Escalate complaints and customer feedback to internal commercial and quality teams
Process requests for complaint details, data, and credit reports
Provide reports to commercial team members
Participate in customer meetings as needed
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; 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 healthy lives