Quality Engineer Tech

Plans, coordinates, and directs quality control programs designed to ensure continuous production of products consistent with established FDA and ISO standards.Designs and implements quality control training programs.Investigates and adjusts customer complaints regarding quality.Serves as project leader on project teams designated to resolve issues and implement solutions.Fully versed in Document Control processes and procedures.Assists in reviewing and revising processes within the QCBD (Quality Management System).Provides inspection activity for product throughout production cycle.Applies total quality management tools and approaches to analytical and reporting processes within each department.Creates, implements, updates and maintains work instructions, partnering with the Engineering and other departments.Creates and directs process/equipment validations.Directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products.Works with suppliers to ensure quality of all purchased parts for company use.Must work responsibly with or without supervision using effective communication skills; able to collaborate with various departments and all levels of team members.Helps reduce scrap/waste, cost, time; drives for continuous improvement.Reliable, timely, ethical and consistent attendance.Travels to another facility and/or customer/vendor sites based on company needs is required.Other duties as assigned.QualificationsBachelor's degree in applicable technical discipline such as mechanical or bio-medical engineering is strongly preferred or equivalent,or five to ten years of experience in medical device manufacturing industry and in the quality engineering role, and/or training,or equivalent combination of education and experience.Knowledge of the medical device manufacturing industry.Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations.Knowledge of Geometric Dimensioning and Tolerancing per ASME Y14.5M.Familiarity with test methods and standards for the design, verification, and validation of medical device products is required.