Tina Hudson, Senior Quality Engineering Consultant joined QA Consulting Inc. in 2017 with eighteen years of medical device and diagnostic industry experience. Tina provides project management and consulting services to her clients in all areas of quality system management with specialization in design controls, production and processing controls, risk management and purchasing controls.
Much of Tina's quality management knowledge and experience was honed during her twelve year tenure at Roche working with hardware and software medical devices. While at Roche she held various leadership roles in engineering and operations, with responsibility for product and process design, design transfer, manufacturing, partner relations, and ongoing life cycle management. She has significant experience with product commercialization, leading a Project Management Office (PMO) that was responsible for the flawless launch of hundreds of new product introductions (assays, instruments, and point-of-care devices). Throughout her career Tina has been a strong champion of continuous improvement, utilizing FMEA, DMAIC, PDCA, LEAN and other tools to improve quality, reduce waste, and increase efficiency across a broad range of business and manufacturing processes.
In addition to her Fortune 500 experience, Tina led program management and engineering departments for start-up companies most recently within the oncology diagnostic (IVD) space. She provided leadership and oversight to the new product development, with ownership for design control, process validation, manufacturing, and supplier quality compliance. She also supported CLIA lab accreditation and implementation of a Centers for Medicare and Medicaid Services (CMS) compliant quality system.
Tina has a BS degree in Chemical Engineering and spent the first part of her professional career with Eastman Chemical Company in their coatings and plastics area.