Dani Bar-Lev

Background

About Dani Bar-Lev

Experienced senior executive manager with a demonstrated history of working in Medical Devices and Semiconductors industry's covering Operations, Engineering, Research and Development [R&D], Quality and Regulatory leadership roles with various global projects, initiatives and multi sites collaborations.~25+ years of progressive experience with proven record of significant, successful contribution in Quality management systems, Project management, Process improvements, Business analysis/evaluation, Design controls, Supplier management, Standards and regulations, Manufacturing, Engineering and Purchasing. Startups experience – Bringing Concept to Commercial phase, Foundation of cross business processes towards medical device company certification, establishment of Quality management systems [QMS] from scratch, Implementation, Improvement and adjustment of processes, Mentoring cross functional teams; R&D, Clinical, Engineering, Purchasing, Supply chain, QA/RA, Management and manufacturing teams. Vast experience with processes and methodologies; Manufacturing, Engineering, Suppliers, purchasing, product quality and QMS, clinical processes, regulatory submissions, lean and cost reduction activities. FDA inspections experience, Notified bodies and other regulatory bodies (CE, MDR, MDD, ISO13485, ISO9001, QSR, ANVISA and etc.) Proactive self-starter with track record of initiative, personal responsibility, ownership of work and reputation for execution and removing obstacles for making things happen. Strong leader which effectively motivates others and directs top-level strategic company initiatives. A Certified Executive Director by Reichman University - FORE Executives.