Product Complaints Engineer

DEKA R&D, on behalf of Millyard Advanced Technologies,is looking for a Product Complaints Engineer to work in a dynamic Medical Device Research and Development environment.  The position reports to the Product Complaints Manager.  This is a high visibility role with a significant direct impact in the Quality Management System.

How you will make an impact:

+ Responsible for reviewing complaints related to potential medical device issues. 

+ Perform product complaint evaluations with minimal direction, utilizing experience and product knowledge.

+ Ensure that complaint documentation follows Good Documentation Practices; meets QMS requirements; and complies with U.S. Food and Drug Administration (FDA) regulations / other regulatory requirements.

+ Identify and make sound decisions regarding medical device reporting to regulatory agencies.

+ Interface with Third Party Manufacturers, health care professionals, internal customers, and reg...

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