Asish Ghosh

Background

About Asish Ghosh

QUALITY & REGULATORY; PROGRAMS MANAGEMENT OFFICE (PMO); DEVELOPMENT & MANUFACTURING ENGINEERING/TECHNOLOGY MANAGEMENTI have comprehensive experience in Operations, including manufacturing and software products. Experience in leading, managing, facilitating and mentoring teams in Program Management, Design & Manufacturing Engineering, Technology Management, and Quality/Regulatory functions. I consistently create innovative solutions that exceed customer expectations by seamlessly blending expertise in these functional areas, across internal and external teams. I have worked on programs which resulted in either, or a combination of, increased revenue, reduced cost or, improved quality, while meeting business objectives. Key topics where I have a track record in the 3 functional areas are:QUALITY & REGULATORY: FDA Class 2 medical devices certification, ISO Certification, Regulatory & Standards Compliance (FDA, MDD etc.), Lean Six Sigma, Change Acceleration Process (CAP), Vendor / Supplier management, Quality assurance, Quality & Regulatory Testing, Design Controls, Design Transfer, V & VPROGRAMS MANAGEMENT: Collaborative research, Globalization, Acquisition integration, Business development, Organizational readiness, PMO (Programs Management Office) Strategy, Design & Management, Budgeting & resource planning, Scheduling & Trade off analysis, DEVELOPMENT & MANUFACTURING ENGINEERING / TECHNOLOGY MANAGEMENT: Research and development, Product development, Road map and strategy development, Manufacturing and Development engineering management, Supplier relationship management, Global team management