Quality Engineer

Overview:Manages all quality aspects within assigned projects such as: compliance with applicable norms and regulatory requirements, risk management, design verification, validation, design history file, design change control, CAPAs, and design transferDevelops and utilizes quality tools within the Chicago Innovation CenterSupports the development and implementation and improvement of the Quality Management System (QMS) Work within defined procedures for development including quality, environmental health and safety requirements, confidentiality, and good manufacturing practicesResponsibilities:Supports and challenges project team on all aspects of qualityApproves relevant project documentation per approved development procedure checklistsParticipates in project risk management activities ensuring that tools such as the Risk Management Plan, Risk Management Report and FMEA are properly used (product and process de-risking).Follows up and reports project status regularly to the Unit Quality ManagerParticipates in internal auditsActively participates in the QMS maintenance and improvementParticipates in the creation of, and ensures completion of, design control documentation for product development programsEnsures quality of program documentation, including traceabilityEnsures quality of the developed products