This individual will be expected to apply his/her knowledge of product, development principles, and quality engineering to develop procedures and processes that ensure sustaining activities and successful development of products to positively influence commercial and/or new product launches to ensure they are developed, validated / qualified, and manufactured in accordance with regulatory and quality requirements. Overview: · The primary purpose of this position is to lead Quality Engineering (QE) activities for product and process support including Validation of Manufacturing Processes, Cleaning Processes, and Test Methods, Qualification of Equipment, Utilities, and Facilities, Risk Management, and Annual Product Reviews.