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, in...