Alexandre Izmailov

PhD with 25+ years of experience in managing development of new instrumentation for biomedical applications, Quality Assurance and Project management. Extensive management experience as a VP of Product development leading multifunctional teams. Experience working in regulated environment (ISO 13485). 

• 20+ years of management experience in R&D, engineering, product development, product support, manufacturing, and QA/QC related to advanced products and processes in biotechnology, medicine, chemistry and spectroscopy including FDA approved instrumentation.
• Extensive experience in Project Management including complex projects involving internal and external multifunctional groups.
• Experience establishing productive collaboration with different functional groups within a company including QA, manufacturing, R&D, SW, etc. and with external developers and contractors. Ability to lead multifunctional groups directing them towards a common goal.
• Experience in establishing and maintaining Quality Management Systems, organizing company activities in compliance with ISO 13485 and associated directives, in leading internal and external quality audits, organizing verification and validation activities.
• Extensive experience in hiring and effective management of human resources: selecting and hiring appropriate specialists for R&D, QA/QC and manufacturing, building effective teams for successful resolution of technical problems and meeting planned deliverables, timelines and budgets.
• Extensive experience in troubleshooting of equipment malfunction and finding solution for elimination of technical problems. Experience in establishing and effective use of the CAPA system and project and process risk analysis.
• Ability to effectively use Inventive and innovative approaches to complex problem solving and managing IP related activities of the company.

PhD in Physics. Courses: ISO:13485, Lead audit, SolidWorks, Project Management, Finance for nonfinancial managers etc.