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Hours Full-time, Part-time
Location Batesville, IN
Batesville, Indiana

About this job

This is a 3+ month project to reduce the complaint backlog. Also titled QA/RA Specialist (Quality Assurance/Regulatory Assurance Specialist). This individual will be responsible for processing complaints within the companies software applications. Will track and communicate issues regarding complaints with products (hospital beds, in-home healthcare products, patient mattresses/surfaces, patient furniture, ect). Will identify safety issues and initiate investigation requirements per complaints.

* Manages complaint workflow and processes complaints within software applications.
* Manages potentially reportable event workflow and processes within software applications.
* Determines MDR (Medical Device Records) and Vigilance reportability based on an understanding of the risks associated with product malfunction
* Serves as the contact for quality and regulatory related matters once determined there is a quality issue with the product.
* Communicates with customers to establish a full understanding of the issues.
* Analyzes data (key metrics) for all product development, manufacturing and distribution operations.
* Analyzes trends in data for the purpose of initiating corrective actions to resolve or prevent product issues
* Identifies, communicates and tracks high priority issues relating to safety, complaints and systemic customer satisfaction.
* Enables and recommends rapid and effective correction of quality/regulatory problems in a manner that prevents their reoccurrence.

About Aerotek:

Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit .