Results- and data-driven engineering and management team leader with 18+ years experience in life sciences quality management, product & project management, design assurance, and R&D; B2B SaaS eQMS startup cofounder with exit. • Expertise in catheter-based implants (uro/endo/colono-scope + endovascular) and software products • 10 years managing others• Design & Development | Design Controls• Supplier Qualification / Controls, Auditor• FDA, CA FDB, Notified Body, facilitator• Metrics/KPIs architect• Passion for Improving Quality & Patient Care • Numerous Class II and III device commercialization launches / studies / withdrawals• Continuous improvement champion / sponsor• 21 CFR Parts 11, 820; ISOs 13485, 9001, 14971, 10993-1, IECs 62366, 62304, 60601, ICH, GAMP 5, SOC 2(banner Image by usertrmk on Freepik)
Listed skills include Iso 13485, Quality System, Capa, Medical Devices, and 46 others.