Dale Severs

Background

About Dale Severs

45 years of experience with the realization of medical devices and pharmaceuticals. 35 years of experience constructing and maintaining aircraft and aircraft systems. Manufacturing processes development, implementation and validation of mixing, aseptic filling, sterilization, assembly, heat-sealing, extrusion, packaging, printing, molding, coating and forming technologies. Audit leadership of ISO13485, 62304, 14971 and 21 CFR 820 compliance. Medical device product development, verification and validation. Quality system development including risk management, design control, supplier qualification, manufactured product acceptance, product surveillance and CAPA. Design history, master record and device history file development and change management. Process automation software, equipment and facilities development and validation. Automated test methods including pressure decay, computer vision, gas and capacitance. Industrial information technology software, networks and workstation validation. Experienced with Track Wise, DOORS, My Workshop, EPDM, and Documentum Aircraft development, construction, certification and maintenance. FAA A&P/IA certifications