Job Description
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...
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...