Sr. Quality Compliance Engineer

Investigate complaints daily:

• o Responsible for quality compliance duties relating to customer complaints, including but not limited to preliminary classification of complaints, customer and product follow ups, maintaining investigation records and all other supporting documentations, and assign additional actions as necessary to close complaint.


• o Ensures complaints are processed thoroughly and timely in compliance with departmental procedures and metrics.


• o Performs and documents initial reportability decisions on complaints in accordance with regulations (US FDA) and international regulations (MEDDEV Vigilance, Health Canada, and others as applicable) and company procedures; Elevate complaints that require additional review for regulatory reporting.


• o Verify that the correct number of complaints have been opened to address all of the issues identified in the complaint description. If required, generate addi...