Fresenius Kabi USA
Product Complaint Support Rep
Fresenius Kabi USA, Lake Zurich, Illinois, United States, 60047
Base pay range
50,000.00/yr - 60,000.00/yr
This position is customer facing and acts as the first point of contact for all quality related product defects for MedTech within Region North America. It supports the timely and accurate processing of customer complaints to meet regulatory obligations and customer needs.
Responsibilities
Manage workflow for all quality related inquiries (internal and external).
Evaluate initial complaints for investigation within the Global Complaint Management Workflow (gCMW).
Capture commodity information in GCMW and ensure necessary documentation is captured prior to closure.
Follow up with customers to collect required information as per SOPs/regulations.
Coordinate sample retrieval, return tracking and follow‑ups.
Coordinate quality related product returns with Post‑Market Quality Assurance and Customer Service.
Evaluate and authorize customer credit when applicable.
Provide timely responses to customers (written or verbal), including receipts, status updates and final evaluation letters.
Attend product specific monthly Product Review Meetings and report updates to the MedTech Commercial Organization.
Escalate customer and product specific complaints to the internal commercial team for proactive support.
Process requests from commercial team for data, customer complaint details, credit reports, etc. and provide reports.
Participate in customer meetings as needed.
Escalate customer feedback regarding quality related processes.
Collaborate with Post‑Market Quality Assurance/Quality Engineers on trends, complaint investigation activities and process improvements.
Assist Divisional Post‑Market Quality Assurance Team and product line Quality Engineer in investigation of high‑risk complaints.
Ensure compliance with company documents and management systems per role responsibilities.
Requirements
Bachelor’s degree preferred.
Experience with SAP preferred.
1–3 years of customer facing and/or quality related experience. Knowledge of FDA quality systems and Medical Device Reporting regulations (21 CFR 803, 820 & 211; Part 11) is a plus.
Ability to prioritize multiple risk projects to ensure compliance.
Excellent written and verbal communication and organizational skills.
Strong problem‑solving and analytical skills.
Flexibility to work on new products/assignments.
Strong interpersonal skills and ability to work with cross‑functional teams.
Self‑motivated and quick learner.
Exceptional customer service focus.
Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, life insurance, disability, 401K with company contribution, and a wellness program.
Seniority level Entry level
Employment type Full‑time
Job function Customer Service and Quality Assurance
Industries Medical Equipment Manufacturing
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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This position is customer facing and acts as the first point of contact for all quality related product defects for MedTech within Region North America. It supports the timely and accurate processing of customer complaints to meet regulatory obligations and customer needs.
Responsibilities
Manage workflow for all quality related inquiries (internal and external).
Evaluate initial complaints for investigation within the Global Complaint Management Workflow (gCMW).
Capture commodity information in GCMW and ensure necessary documentation is captured prior to closure.
Follow up with customers to collect required information as per SOPs/regulations.
Coordinate sample retrieval, return tracking and follow‑ups.
Coordinate quality related product returns with Post‑Market Quality Assurance and Customer Service.
Evaluate and authorize customer credit when applicable.
Provide timely responses to customers (written or verbal), including receipts, status updates and final evaluation letters.
Attend product specific monthly Product Review Meetings and report updates to the MedTech Commercial Organization.
Escalate customer and product specific complaints to the internal commercial team for proactive support.
Process requests from commercial team for data, customer complaint details, credit reports, etc. and provide reports.
Participate in customer meetings as needed.
Escalate customer feedback regarding quality related processes.
Collaborate with Post‑Market Quality Assurance/Quality Engineers on trends, complaint investigation activities and process improvements.
Assist Divisional Post‑Market Quality Assurance Team and product line Quality Engineer in investigation of high‑risk complaints.
Ensure compliance with company documents and management systems per role responsibilities.
Requirements
Bachelor’s degree preferred.
Experience with SAP preferred.
1–3 years of customer facing and/or quality related experience. Knowledge of FDA quality systems and Medical Device Reporting regulations (21 CFR 803, 820 & 211; Part 11) is a plus.
Ability to prioritize multiple risk projects to ensure compliance.
Excellent written and verbal communication and organizational skills.
Strong problem‑solving and analytical skills.
Flexibility to work on new products/assignments.
Strong interpersonal skills and ability to work with cross‑functional teams.
Self‑motivated and quick learner.
Exceptional customer service focus.
Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, life insurance, disability, 401K with company contribution, and a wellness program.
Seniority level Entry level
Employment type Full‑time
Job function Customer Service and Quality Assurance
Industries Medical Equipment Manufacturing
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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