Mike Shaked
About Mike Shaked
Mike Shaked is a QA Manager currently working at Tosca in Northern Israel since 2021. He has a diverse background in project management and engineering, with extensive experience in quality control and regulatory compliance in the medical device industry.
Current Role at Tosca
Mike Shaked serves as the QA Manager at Tosca, a position he has held since 2021. He is based in Northern Israel and has been responsible for overseeing quality assurance processes within the organization. His role involves ensuring that production processes meet established standards and regulatory requirements.
Previous Experience in Medical Device Industry
Before joining Tosca, Mike Shaked worked at GSAP as Development and Quality Project Manager for medical devices from 2017 to 2020. He also held key positions at MST - Medical Surgery Technologies as Project Manager in the Operation Department from 2014 to 2017, and at Lumenis as Product Manager in the Engineering Department from 2007 to 2011. His experience in these roles contributed to his expertise in managing quality controls and enhancements.
Educational Background
Mike Shaked studied at Derby University from 2000 to 2008, completing an eight-year program. He also attended Technion-Machon Technologi Le' Israel, where he studied Electronics & Computers and achieved the designation of Practical Engineer from 1995 to 1998. Additionally, he studied at Ort Grinberg from 1981 to 1987.
Expertise in Quality Assurance and Engineering
Mike possesses extensive expertise in production processes that comply with standards such as ISO 13485, CFR 820, and CE. He has a strong background in optimizing products and processes for cost reduction while maintaining project scopes. His experience includes managing CAPAs, NCs, and Complaints projects, which have contributed to improvements in product quality.
Diverse Engineering Experience
Mike Shaked has a diverse engineering background, having worked in various roles across different companies. He served as an Electronic Engineer in the R&D Department at Jordan Valley from 2004 to 2007 and as a Practical Engineer at Nanomotion from 1997 to 2001. He also worked at Elbit as a Practical Engineer in the System Department from 2001 to 2004. This varied experience has equipped him with a deep understanding of engineering documentation and configuration control.