Katherine M. Erdley
Director of Quality Assurance, Actuated Medical, I
Quality Assurance
Actuated Medicals
United States of America
Biography
Ms. Katherine M. Erdley, also known as Katie, serves as Director of Quality Assurance at Actuated Medical, Inc. Ms. Erdley is responsible for managing Actuated Medical's ISO-certified quality management system (QMS). She ensures design and manufacturing compliance to ISO 13485, ISO 14971, 21 CFR 820 and Medical Devices Directive 93/42/EEC, with a focus on proactive risk management while maintaining innovative development. She also guides best quality system documentation to ensure that design history files, device master records and other documentation follow the 7-stages of development that enables ease of transition into acquirers' QMS. She has a wellrounded background with experience in pharmaceutical and medical device industries, lean/six sigma, engineering, project management and quality system management. Ms. Erdley earned her B.S. in Industrial Engineering from Penn State.
Research Interest
Business
