Product Complaint & Support Representative

Fresenius Kabi USA•Chicago, IL

1d•$50,000 - $60,000•Onsite

About The Position

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. This position also supports the timely and accurate processing of customer complaints to help ensure Fresenius Kabi complies with all its regulatory obligations and meets the customers’ needs. Serves as primary contact and support for customers and Medical Device Commercial Organization for quality related complaints.

Requirements

Bachelor Degree preferred.
SAP experience is 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 to ensure compliance with regulations and standard operating procedures.
Excellent written/verbal communication and organizational skills.
Strong problem solving and analytical skills.
Flexibility to work on new products/assignments.
Strong computer skills (e.g. Word, Excel).
Strong interpersonal skills and the ability to work with cross-functional teams.
Self-motivated and quick learner.
Exceptional customer service focus
The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Responsibilities

Manage workflow for all quality related inquiries (internal and external).
Evaluate initial complaints for need to investigate within the Global Complaint Management Workflow(gCMW).
Capture all complaint information in Global Complaint Management Workflow and ensure all necessary documentation (i.e. sample information, root cause information, etc.) is captured prior to closure, if available.
Follow up with customers to collect required information as indicated per Standard Operating Procedures/regulations, or requested by Post Market Quality Assurance
Coordination and execution of the sample retrieval, sample return tracking and sample return follow ups.
Coordinate quality related product returns with Post Market Quality Assurance and Customer Service.
Evaluate and authorize customer credit, if applicable.
Provide timely response to customers (written or verbally) including receipt of complaint, status updates, and final evaluation letters.
Attend product specific monthly Product Review Meetings and report out updates to the MedTech Commercial Organization, as needed.
Escalate customer and product specific complaints to the internal commercial team for awareness and proactive customer support, as needed.
Process requests from commercial team for data, customer complaint details, credit reports, etc. Provide reports to commercial team members in order to respond to customer needs.
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, as needed.
Assist Divisional Post Market Quality Assurance Team and product line Quality Engineer in investigation of high risk complaints, as needed.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.