• A dynamic professional of exposure to medical domain.• Knowledge on Design verification activities of medical device.• Good understanding on manufacturing processes.• Proficient in change control process.• Endowed with a passion for winning as evinced through demonstrated excellence in the academic &extracurricular areas.• Preparing GSPR gap assessment and checklist as per ISO13485.• Processing Engineering Change Management (ACR, ECN/ECO Process).• Study product samples, understand the client’s requirement, work with the cross functional team likegraphics and labelling update and document it as per the regulation.• Develop and maintain detailed databases of appropriate reference materials, including research,usability tests, and design specifications.• To pull the corresponding documents from SAP and coordinate with the respective region, to confirmwith the approvers that its update has no negative impact with respect to the regulation standardsISO13485 and can be implemented• Test report verification & validation protocol.• Firm understanding of the systems development life cycle (SDLC)

• A dynamic professional of exposure to medical domain.• Knowledge on Design verification activities of medical device.• Good understanding on manufacturing processes.• Proficient in change control process.• Endowed with a passion for winning as evinced through demonstrated excellence in the academic &extracurricular areas.• Preparing GSPR gap assessment and checklist as per ISO13485.• Processing Engineering Change Management (ACR, ECN/ECO Process).• Study product samples, understand the client’s requirement, work with the cross functional team likegraphics and labelling update and document it as per the regulation.• Develop and maintain detailed databases of appropriate reference materials, including research,usability tests, and design specifications.• To pull the corresponding documents from SAP and coordinate with the respective region, to confirmwith the approvers that its update has no negative impact with respect to the regulation standardsISO13485 and can be implemented• Test report verification & validation protocol.• Firm understanding of the systems development life cycle (SDLC)