Tamal Ghosh
Design Quality Engineer @Ethicon Endo-Surgery, Inc
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WORK HISTORY
Design Quality Engineer @Ethicon Endo-Surgery, Inc
Blue Ash, OH, US
Design Quality Assurance activities of Endo-mech medical devices, Manages project, Leading offshore team, Planning resources, Manages project stakeholders, Consult and co-ordinate with multiple customers and understand the requirement and act accordingly.
EDUCATION
Kalyani Govt. Engineering College
Bachelor of Technology (B.Tech.), Mechanical Engineering/Mechanical Technology/Technician
SKILLS
ABOUT TAMAL GHOSH
Experience in QUALITY and REGULATORY Projects in Medical Devices and Diagnostics Domain. Key Domain Knowledge areas:1. Medical Device Quality Management System ISO 13485:20162. Medical Device Risk Management ISO 14971:20193. Medical Device Regulation (FDA 21 CFR 820/822/801/803/806 and others, EUMDR, TGA, ANVISA, SOR/98-282)Skills:1. Design Quality Engineering2. Document control/ Change Management3. Risk Management4. Sustenance Engineering5. Value Engineering6. Post Market Surveillance7. Medical device Labelling8. Six-SigmaBusiness skills :1. Project Management 2. Team Leadership3. Resource Management
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