Anantha Kumar
Design Quality Assurance at Philips | 11+ years in Q&R field | Medical Devices | SaMD | Regulatory Affairs | ISO 13485 | EU MDR | Supplier Quality
- Role
- Design Quality Engineer at Philips
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Anantha Kumar
Having 11+ years of experience in Quality and Regulatory domain - Medical Devices…
Experience
Design Quality Engineer
Sep 2021 — Present · Bengaluru, IN
Responsible for ensuring the fulfillment of design control requirements throughout the SDLC- Providing guidance to the R&D team in interpreting and implementing the various activities part of SDLC against the company policies to ensure compliance- Conducting and managing the risk management activities from the early stages of development throughout the life cycle of the product- Review and approve the development, verification, and validation strategies- Review and approval of work products such as plans, requirements, design, risk documents, test protocols, test results, traceability, and relevant reports part of the Design History File in accordance with the design control guidelines and company policies- Responsible for validation of SOUP & non-product software using the product development- Participated in client-supplier audits, and internal audits and was responsible for remediating the findings through CAPA
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