Keru Shafi, MBA, Cqe
About Keru Shafi, MBA, Cqe
Keru Shafi is a Principal Quality Design Engineer with extensive experience in quality management and product development in the pharmaceutical and medical device industries. He has held key positions at notable companies such as Teva Pharmaceuticals, Haemonetics, and Johnson & Johnson, and currently works at InCube Labs, focusing on innovative combination products.
Work at InCube Labs
Keru Shafi serves as the Principal Quality Design Engineer at InCube Labs, a position held since 2018. In this role, he manages design controls and risk management for First-in-Human combination product clinical studies. He provides guidance and support to cross-functional teams, focusing on project planning, problem-solving, and quality procedures. His responsibilities include ensuring compliance with Quality Management System (QMS) processes and leading the development of innovative medical products.
Previous Experience at Teva Pharmaceuticals
Prior to his current role, Keru Shafi worked at Teva Pharmaceuticals as a Senior Pharmaceutical Chemist from 2004 to 2007 in Irvine, California. During his three years at Teva, he contributed to pharmaceutical development and quality assurance processes, leveraging his expertise in the field.
Career at Haemonetics / Pall Corporation
Keru Shafi held the position of Principal Product Development Engineer at Haemonetics / Pall Corporation from 2007 to 2016 in Covina, California. Over the course of nine years, he focused on product development and quality engineering, playing a significant role in advancing medical technologies and ensuring product safety.
Experience at Johnson & Johnson
From 1991 to 2003, Keru Shafi worked at Johnson & Johnson as a Senior Materials Specialist in Mountain View, California. His twelve years in this role involved material selection and quality assurance, contributing to the development of various medical products and ensuring compliance with industry standards.
Education and Expertise
Keru Shafi holds a Bachelor's Degree in Industrial Technology with an emphasis in Polymer Science from California State University, Chico. He also earned a Master of Business Administration (M.B.A.) in High Tech Management from Northeastern University. Furthering his education, he completed the Stanford Advanced Project Management program at Stanford University and studied Project Management at UC Irvine. His educational background supports his expertise in quality design and project management.