Medtronic is an Equal Opportunity/Affirmative Action Employer
This position has the responsibility and authority to have expert-level knowledge of product quality complaint investigation, communication, documentation and regulatory reporting procedures for international and domestic geographies. This individual has the responsibility and authority to facilitate cross-functional review and timely implementation of corrective and preventive actions for the complaint handling and non-conformance systems. This position has the responsibility to drive improvements within the complaint handling process and efficiently manages the open complaints and communications with the customers.
Investigates and resolves complaints as required by Regulatory agency regulations or Medtronic regulatory liaisons in accordance with departmental procedures, global laws, and regulations associated with Complaint Handling and Medical Device Reporting.
Provides documentation of product compliments, inquires and complaints, and communicates customer complaints related to the performance of Medtronic ENT products and devices, and advises other department members on their complaint files.
Facilitates quality awareness for department and internal customers. Performs or assigns investigation, root cause analysis, corrective/preventive action for product quality complaints. When necessary, works with or supervises cross-functional teams to facilitate the implementation of corrective / preventive actions. This may involve the initial review of customer complaints, analysis of root cause, investigation, trending, and follow-up of corrective / preventive actions.
Monitors the Customer Loyalty Department’s activity to ensure timely complaint resolution and promotes customer satisfaction to meet or exceed departmental and regulatory requirements regarding product complaints.
Maintains and monitors listening posts for customer feedback to Corrective Action owners. Communicates with Customers, Business Teams, Customer Service, Production, Credit, Shipping, Receiving, Research & Development, Marketing, Sales and Service and Repair departments to coordinate resolution of product quality complaints.
Performs trending of product quality complaints to identify changes that indicate need for investigation or to indicate verification of corrective actions previously implemented.
Identifies high-level complaints or incidents that may have significant impact on the company. Notifies management in a timely manner when high-level complaints are identified.
Drives improvements within the complaint handling process and efficiently manages open complaints.
Supervise and oversee resources within the complaint handling group to ensure documentation, communication and investigation of complaints are done per the QS requirements.
Proficiency in SAP, MS Office, and Global Complaint Handling (GCH) System software.
Basic problem solving and statistical skills for proper complaint investigations.
Knowledge of PC hardware/software operation is required for complaint research, documentation and archives.
Basic skills in the use of microscope, micrometer, and other laboratory equipment.
Good oral and written communication skills.
Good presentation skills.
Must be able to handle multiple tasks/projects and manage priorities accordingly.
Must have a high tolerance for ambiguity.
A BA/BS degree is required with a minimum of five years of product complaint investigation or equivalent experience.
ASQ certification highly desirable.
Medtronic ENT products and information systems knowledge is preferred
Requires a minimum of 3 years experience working within Medical Device industry.
Supervisory or team lead experience is preferred
Physical Job Requirements
The physical demands described within the main job duties / responsibilities section of this job description and representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
During the course of regular assigned duties, the employee may be required to properly utilize personal protective equipment including but not limited to: safety shoes, safety glasses, goggles, hard hats, air purifying respirator or supplied air respiratory protection.
The employee must be able to lift 10 pounds per job requirement.
Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...