Roberta Goode is an executive with over 25 years of experience in the medical device industry. She is currently President and CEO of Goode Compliance International (GCI), a global leader in engineering and compliance services for medical device manufacturers, specializing in process validation, design control, and risk management. Prior to founding GCI in 2002, Ms. Goode held positions of increasing responsibility in R&D, Manufacturing, and Quality Engineering at Beckman-Coulter Corporation, Althin Medical, Inc. (acquired by Baxter Healthcare), and Cordis Corporation (a Johnson & Johnson company), where she contributed intellectual property in the form of four U.S. patents for percutaneous cardiovascular interventional devices. She holds a Master of Science degree in Biomedical Engineering and a Bachelor of Science degree from the University of Miami. Additionally, Ms. Goode has an adjunct faculty appointment at the University of Miami’s College of Engineering and is an ASQ Certified Quality Engineer.
Vice President of Operations
Jeremy Cortese is an engineer with over 14 years experience in numerous industries. He is currently Vice President of Operations at Goode Compliance International (GCI), a global leader in engineering and compliance services for medical device manufacturers, specializing in process validation, design control, and risk management. Prior to joining GCI in 2006, Jeremy held positions of increasing responsibility in process development and manufacturing at Lucent Technologies (merged with Alcatel in 2006), Corning Incorporated, and Boston Scientific, where he contributed to the development of new and innovative processes and supported the successful launch of guidewire products for Urology, Interventional Cardiology, and Vascular surgery. He holds a Bachelor of Science degree in Mechanical Engineering from Purdue University and is a certified quality engineer (CQE), as well as a certified Six Sigma professional (CSSGB).
Co-Founder of Goode Consulting International (now Goode Compliance International) in 2002, Greg Goode provides the strategic direction for the company and manages the financial aspects of the organization. With significant assistance from the executive team, Greg positions GCI to help medical device manufacturers navigate complex regulations and threats from overseas markets. Before the inception of GCI, Greg was a partner in the development of a successful IT consulting and training organization located in Ft. Lauderdale, Florida. After the company met its goal of selling to investors, Greg was appointed President for two years before moving on to co-found GCI. Greg’s vision for GCI is to steadily increase revenues to $100 million by expanding GCI’s local presence in major medical device manufacturing markets and partnering with dozens of accredited biomedical engineering universities. He holds a Bachelor of Science degree in Computer Science from the Florida Institute of Technology.
Ankita Kulhari has over 12 years of experience in the medical device industry as a biomedical engineer. She is currently a Project Manager at Goode Compliance International (GCI), where she leads multiple projects in CE Mark Recertification, Design History File Remediation, Risk Management, Supplier Quality Management, Standards Assessment, Sterilization, and Biocompatibility. She is a detail-oriented subject matter expert in Technical Files, Design Dossiers, Design History Files, EN ISO 10993, EN ISO 13485, 21 CFR 820, EN ISO 14971, and Medical Device Directive 93/42/EEC across various indications for use and therapeutic areas. She holds a Bachelor of Science degree in Biomedical Engineering from the University of Miami and is a RABQSA-certified lead auditor.
Michael Garcia is an engineer with over 11 years of experience in the medical device and biotechnology industries. He is currently a Program Manager at Goode Compliance International (GCI), where he is responsible for numerous client accounts. Michael leads multiple projects in Test Method Validation, CE Mark Recertification, Design History File Remediation, Risk Management, and Supplier Quality Management. Prior to joining GCI, Michael worked as a Project Manager at CR Bard, Sr. Manufacturing Engineer at Pall Life Sciences, and Director of Business Development and Project Manager of an engineering-consulting firm he co-owned. He has led several teams for projects performed in companies such as Pall Biomedical (now Haemonetics), St. Jude Medical, Patheon/Mova, Stryker, and Pall Life Sciences. Michael holds a Bachelor of Science degree in Mechanical Engineering from the University of Puerto Rico Mayaguez Campus and has been trained in Six Sigma. He is also a certified Project Management Professional (PMP).