SUMMARY: This position is responsible for ensuring production and process control compliance during the development and manufacturing of medical devices at the Nextern Maple Grove facility. This position may also involve quality assurance of product conformance for dimensional, electrical, and visual workmanship standards in accordance with requirements.

DUTIES AND RESPONSIBILITIES:

· Responsible for ensuring production and process control compliance during the development and manufacturing of medical devices. Including, but not limited to, direct monitoring and correction/training of production staff.

· Perform comprehensive manufacturing Device History Record (DHR) review at close of manufacturing process and product release.

· Makes decisions on how to handle product issues with the operator accordingly and matters pertaining to whether or not product is acceptable.

· Identifies and evaluates procedures to ensure the pr...