Director, Solutions Delivery
Terry Gustafson has over 20 years of diverse experience in the Medical Device, Pharmaceutical, and Biotechnology industries. He has managed several remediation projects related to FDA 483 and/or warning letters. He has deep expertise in FDA Regulatory Compliance to US and international standards along with deep expertise in Quality Systems and Quality Engineering from product development to manufacturing. Additionally, he is an ASQ certified Black Belt, expert in the application of Lean and Six Sigma methodologies.
His auditing experience encompasses internal and external GMP, QSR, Quality, and Supplier auditing for cGMP, ISO 9001, and 13485 environments. Terry is an ASQ Certified Biomedical Auditor, (CBA). His process expertise includes product design and development, Class I, II, III medical devices, drug components, combination devices, quality systems design and reengineering, risk management, change management, statistical process controls, CAPA, complaints, automated assembly and inspection, packaging, injection molding and extrusion, machined components, and plastic assembly processes. Terry has extensive experience validating all of these processes. His computer systems experience includes local area networks, plant data systems, human interfaces, and PLC/SCADA systems. Terry also has college level teaching and training experience in many of the above areas. Terry has a BS in Electrical Engineering from the University of Illinois.
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