Vadim Kastin Email & Phone Number

• Quality Assurance leader with excellent leadership capabilities and over 25 years’ experience in Research & Development Control, Regulatory Affairs, Business Quality and Compliance, Quality Operations for Medical.
• System level design and development of tools and processes integration among functional areas, disciplines.
• Quality Systems Compliance and Remediation Programs
• WW Regulatory submissions and compliance
• Product life-cycle management
• Medical Device Discovery Appraisal Program (MDDAP) by FDA

Head of Quality and Compliance, Management Representative for Quality, member of management/leadership board. Developing Quality and Compliance Strategies, focusing to improve customer experience by fitting product to customer needs, specifications and relevant regulatory requirements.

Orange County, California Area

Head of Quality and Compliance, Management Representative for Quality, member of company's leadership board

Responsibility for all WorldWide Quality Assurance functions including new product development, verification and validation, transfer to production, manufacturing and distribution. Management representative for Quality and Management team member. Responsible for Quality Strategy and represent Quality organization in business startegic meetings. Responsible.

Israel

Quality Lead in Biosense Webster Israel, responsible for all Quality and Regulatory Affairs aspects for entire product lifecycle, Quality System and Compliance, represent Quality in management board and Company portfolio strategic group. Responsible for establishment and execution of Quality and Regulatory Strategy of site and its relevant products.

Israel

Head of Quality and Regulatory Affairs of the company, establish and maintain Quality System and Regulatory Submissions for company products, managing communications with multiple regulatory partners and authorities.

Israel

Lead Auditor responsible for performing certification and follow-up audits mainly for medical devices industry. Certified for multiple standards including ISO 13485, ISO 9000 Series, QS 9000, ISO 14000, OHSAS 18000, others. Represented multiple notified bodies such as MDC, DQS, GMED, NSAI, others for certification, technical files review and follow-up.

Israel

Responsible for Quaiity aspects of Product development, manufacturing, subcontractors approval and monitoring, LCM Quality.

Israel

Responsible for all Quality aspects of design, manufacturing and maintenance of machines and tools.

Master Of Business Administration (M.B.A.), Buisness Management / Planning And Marketing, Mba

Master'S Degree, Quality Assurance And Reliability, M.Sc.

Reliability Analysis, Quality Engineering, Statistical Analysis, etc.

Certified Quality Engineer, Quality Engineering, Cqe

Bachelor'S Degree, Mechanical Engineering, B.Sc.

Mechanical Engineering with emphasis on medical devices engineering. Final project is development of SW for glucose rate management.