Vadim Kastin
Owner President at AVP Consulting Agency, Llc @Avp Consulting Agency, Llc
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WORK HISTORY
Owner President at AVP Consulting Agency, Llc @Avp Consulting Agency, Llc
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 Device Sector.• 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• Conformance to EU MDR European Medical Device Regulation 2017/745, ISO 13485:2016 Medical Devices - Quality Management Systems, ISO 14971:2016 Risk Management, IEC 60601-1 Medical Electrical Equipment, IEC 62304 Medical Device Software
EDUCATION
Ben-Gurion University of the Negev
Bachelor's Degree, Mechanical Engineering
Technion - Israel Institute of Technology
Certified Quality Engineer, Quality Engineering
Technion - Israel Institute of Technology
Master of Business Administration (M.B.A.), Buisness management / Planning and marketing
Technion - Israel Institute of Technology
Master's Degree, Quality Assurance and Reliability
SKILLS
ABOUT VADIM KASTIN
Experienced Quality Compliance Leader with a demonstrated history of working in the medical device industry. Skilled in Medical Devices, U.S. Food and Drug Administration (FDA), Design Control, Quality Assurance, and Quality System. Strong quality assurance professional with a Master of Business Administration (M.B.A.) focused in Buisness management / Planning and marketing from Technion - Israel Institute of Technology.
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