Sudha Jagadeesan
Principal Consultant
- Role
- Principal Consultant at Philips
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Sudha Jagadeesan
A result-oriented professional with 20+ years of experience in Quality & Regulatory across domains such as Healthcare and Consumer Lifestyle. Quality Management System (QMS): Enabling the business with End to End QMS in line with standards such as ISO9001, ISO13485, IEC 62304, ISO 9001:2015, EU MDR, SAFe methodology. Definition and roll out of Healthcare Safety Risk management process in line with ISO 14971 standard- Consolidation of multi-site, multi-functional QMS into one common QMS to be used across sites- Execute the role of Site lead for the Product organization, collaborating with cross functional teams (such as PMO, R&D, Service, Marketing, Industrialization, Q&R, Design Experience, Risk Management), cross geographical sites to ensure a positive momentum in embracing the Business transformation - Execute the role of Project manager for rolling out QMS tool such as ARIS- Execute the PMO role in Post merger integration by facilitating the roll out of processes in the new merged business organization - Closely collaborate with global Process experts to align on the process roadmap, releases, providing continuous feedback for process improvements - QMS roll out involves topics such as Quality Manual, processes for Management system, Tool Validation, Advanced Development process, Platform creation process, Product Development process, CAPA, Audit management, Complaint Handling, Safety Risk management - Deep experience in hands on deployment of processes and have achieved successful certifications from notified bodies Information Security Management System (ISMS): Gap analysis and roll out of ISMS processes in line with ISO27001:2022, ISO27002:2022, ISO27005:2022 versions of Standards.
Experience
Principal Consultant
Sep 2018 — Present · Bangalore, IN
Enabling the business with Quality Management System(QMS) in line with standards such as EU MDR, ISO13485, IEC 62304, ISO 9001:2015, SAFe methodology. Definition and roll out of Safety Risk management process in line with ISO 14971 standard-Consolidation of multi site, multi functional QMS into one common QMS in alignment with global Philips Excellence Process Framework (PEPF)-Performing the role of Site lead for the Product organization, collaborating with cross functional teams…
Education
MVJ
Bachelor of Engineering (B.E.), Electrical and Electronics Engineering
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