Quality Engineer

Coordinate with cross-functional team where necessary, including: Receiving, Field Service, Manufacturing, Product Development, Quality, and Regulatory, as well as vertically throughout the organization.
Perform risk assessments utilizing released product risk documentation such as PFMEAs and UFMEAs.
Use data driven approach to decision making process, including evaluation of product performance.
Responsible for making reportability decisions in a timely manner to ensure compliance with FDA regulations.
Write customer letters to inform users about Best Practices or Instructions for Use as needed.
Responsible for supporting field actions and other post market surveillance activities when required.