POSITION SUMMARY: The Design Quality Engineer (DQE) will be responsible for management and execution of assigned quality projects in order to meet quality assurance objectives. The DQE shall have prior experience working within an FDA compliant Title 21 section 820 environment and the ability to work cross-functionally to support rapid growth and continuous improvement.PRIMARY DUTIES AND RESPONSIBILITIES: Conducts detailed root cause investigations and coordinates timely action implementation with the CAPA processEvaluates product changes and directs appropriate disposition of product through the company’s change control systemResponsible for maintaining calibration status of gaging and assessing results of calibration activitiesResponsible for creation of inspection models, inspection prints, gaging, or other inspection documents and detailed testing requirements to insure receipt of quality productSupport concurrent engineering efforts as a participating design team member for product development projects representing quality assurance and the customer (supplier and end user)Participate in hands on cadaver labsReviews product and documentation non-conformances and recommends inspection, product and/or quality system modificationsInterfaces with supplier quality representatives concerning issues with quality assurance and assures that effective corrective action is implementedParticipates in Kaizens, Rapid Improvement Events, and Continuous Improvement programs
