FDA regulated medical device companies are subject to strict timelines when alleged complaints against the devices arise. We will review the application of the DMAIC approach as a first time improvement method to a service oriented unit within the company, dealing with collecting, assessing and reporting medical device complaints, in accordance with 21 CFR 803 (MDR) and 21 CFR 820.198
Sebastian Fishman has worked in both the semiconductor and medical device industry, leading projects for process improvements, scrap reduction, yield improvement, worldwide compliance to regulations, support of regulatory bodies audits, deploying Lean Six Sigma methods; including the development of a Green Belt training and coaching program and providing internal certifications.
Sebastian’s education includes a bachelor’s degree in Chemical Engineering for Textiles and a Master’s degree in Applied Physics for Semiconductor Devices. Additionally, he is a Certified Quality Engineer (CQE) and Certified Manager of Quality / Organizational Excellence (CMQ/OE) by the American Society for Quality (ASQ), a Lean Six Sigma Black Belt from Virginia Commonwealth University (VCU), Quality Systems Regulations (QSR) and Corrective Action and Preventive Action (CAPA) Investigator by PathWise. Sebastian is working on his Master Black Belt certification.
Sebastian was born in Buenos Aires, Argentina, where he studied Textile Engineering. Later on, he moved to Israel where he finalized his degree. He served in the Israeli Army as an Environmental Engineer Assistant. After moving to the US, he completed a Master’s degree at the University of Oregon, that set the pace for the following eight years to work in semiconductor manufacturing. In 2009 he moved to Santa Barbara with his wife and two children, starting his career in the medical device field which continues today. continues today. He has held different roles including project management, quality engineering, operational excellence and technology transfer.
Established in 1963, the Channel Cities section 0709 includes over 170 members from aerospace, manufacturing, healthcare, and service industries.