George Yurkewych
Global Quality Project Manager
About
Team - oriented, hard - working, with outstanding analytical skills and proven track record in developing and launching medical device products for Fortune 500 medical diagnostic / device companies. Launched over fifty medical device products in North America, Europe, Asia, and South America; and holder of two issued patents. Solid core skill set consists of ability to work with complex technical ideas, able to quickly solve problems, effective project management expertise applicable to range of manufacturing industries, and capable of directing teams towards common goals. Proficient in English and Ukrainian, fluent Polish, and conversational Spanish.
United States
Parsippany
Medical Device
Medical Devices, Project Management, Product Launch, ISO 13485, FDA, Cross-functional Team Leadership, Product Management, R&D, Six Sigma, Product Development, Marketing Strategy, Commercialization, Healthcare, Process Improvement, Business Strategy, Design Control, Management, Start-ups, Manufacturing, Program Management
Experience

Global Quality Project Manager
Spectrum Staffing Services/HRStaffers Inc. (Providing Services for ConvaTec)
East Hanover, NJ
Leading Global projects across 4 Business Units (Ostomy, Continence Critical Care, Advanced Wound Care, & Infusion Care) in US, Europe (Belarus, Denmark, England, Poland, Turkey, Slovakia, & Wales) and Central America (Dominican Republic & Mexico). Various projects include Quality cost savings, EU MDR continuous improvement end to end from labelling to manufacturing implementation to country registrations and distribution, global sterilization improvement,, and proof of concept for IT Quality testing in various manufacturing sites.

Project Management Consultant
GJY Consulting
East Hanover, New Jersey

Senior Project Manager
Randstad (Providing services for GlaxoSmithKline Consumers Healthcare)
Warren, New Jersey
Lead key global, strategic, cross-functional innovation projects for the Smokers Health, Multisympton, and Allergy sub categories which are part of the Respiratory Category. Major contributor in the PMO team to the enhancement of Project Management support for the Respiratory category business.

Project Manager
Flanders, New Jersey
As a permanent associate is currently a Project Manager in the Manufacturing organization heavily involved in the transfer of various products from plant to plant. As a contractor lead and coordinated cross functional teams in all aspects of Product Development life cycle. Managed the scope, schedule, and budget of various Laboratory Hematology & Automation projects. Scheduled and lead meetings to coordinate functional project activities to resolve project issues. Identified needed decisions and driving decision making process.

Project Manager
Implemented and manage New Product Commercialization Process for Respiratory Drug Division. Implemented and manage Share Point website to improve communication for the NPCP. Manage multifunctional teams to develop and globally launch several products with annual sales revenues of $5 million. Lead sustaining and technical support projects. Lead the development of a Supply Agreement with a key Manufacturing vendor. Manage project priority planning for RDD on Microsoft Sharepoint.

Product Manager
Managed demand for products through marketing strategies for the blood collection and diabetes markets. Improved product line through line extensions and new product development by increasing sales and profitability for the blood collection and diabetes markets. Led a branding and logo development program for a new diabetes product line. Led and established up an Advisory Board and various clinical panels in the diabetes market. Collaborated with Clinical and Technical Services to develop appropriate training tools.

Senior Project Leader
Managed multifunctional teams to develop and launch globally new generation blood diagnostic collection tubes with revenues of $45 million. Directed multifunctional team in the development and global launch of an innovative lancet with revenues of $30 million. Employed multifunctional team to implement Six Sigma tools resulting in quicker time to market. Routinely assisted the sales force in the inservice of novel hospital blood diagnostics products. Completed efficiently design history files required to maintain NSAI and ISO 9001 certifications. Appointed BDU University instructor for management course: “Coaching for Performance and Development”.
George Yurkewych's Contact Information
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