MedTech Quality Complaints & Support Specialist

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

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability coverage

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA seeks a quality complaints specialist to serve as the first point of contact for quality-related product defects in MedTech within Region North America. You will support processing of customer complaints to ensure regulatory obligations are met and customer needs are addressed.

Responsibilities include coordinating sample retrieval, QA collaboration, and timely customer communications. Requires 1–3 years of relevant experience and a BA/BS preferred.

Qualifications

• Bachelor degree preferred; relevant clinical or quality background is a plus.
• 1–3 years in customer-facing roles or quality-related experience.
• Familiarity with FDA Quality Systems and Medical Device Reporting (21 CFR 803, 820, 211).
• Experience with SAP is preferred and beneficial.
• Strong written and verbal communication skills; ability to prioritize tasks.

Responsibilities

• Manage workflow for all quality-related inquiries (internal and external).
• Evaluate initial complaints for need to investigate within the global workflow.
• Capture complaint information and necessary documentation before closure.
• Follow up with customers to obtain required information per SOPs/regulations.
• Coordinate sample retrieval, tracking, and return follow-ups.
• Coordinate product returns with Post Market QA and Customer Service.
• Evaluate and authorize customer credits when applicable.
• Provide timely responses to customers and finalize evaluation letters.
• Attend monthly Product Review Meetings and report updates to the organization.
• Escalate issues to internal teams for awareness and proactive support.
• Provide data requests and reports to the commercial team as needed.
• Collaborate with Quality Assurance on trends and process improvements.
• Assist in investigations of high-risk complaints with QA teams.

Skills

Customer-facing communication

Quality systems knowledge

Problem solving

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree

Tools

Microsoft Word

Microsoft Excel

SAP

Job description

Fresenius Kabi USA seeks a quality complaints specialist to serve as the first point of contact for quality-related product defects in MedTech within Region North America. You will support processing of customer complaints to ensure regulatory obligations are met and customer needs are addressed.

Responsibilities include coordinating sample retrieval, QA collaboration, and timely customer communications. Requires 1–3 years of relevant experience and a BA/BS preferred.