Rithvik V.
Senior Quality Engineer @Amgen India
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WORK HISTORY
Senior Quality Engineer @Amgen India
Hyderabad, IN
As part of the Combination Product Operations Quality (CPOQ) team, I provide quality oversight and technical support for physical test methods and combination product operations, while managing projects that enhance compliance and efficiency. Key responsibilities include:Method Lifecycle Management: Oversee development, validation, qualification, transfer, and obsolescence of physical test methods for mechanical requirements such as Cap Removal Force, Activation Force, Injection Time, Deliverable Volume, and Needle Extension.Quality Assurance Leadership: Act as QA contact for change controls, deviations, CAPAs, and CAPA Effectiveness Verification, ensuring compliance with global standards.Project Management: Lead and coordinate quality-related projects, managing timelines, resources, and stakeholder communication to achieve deliverables on schedule.Cross-functional Collaboration: Partner with Combination Product Operations, Physical Systems Engineering, and supplier quality teams to review technical documentation and maintain alignment on specifications.Continuous Improvement: Drive initiatives to optimise document review cycles, improve workflows, and enhance operational efficiency within CPOQ.Regulatory Readiness: Ensure inspection readiness and adherence to QMS architecture through proactive engagement and governance.
EDUCATION
MLR Institute of Technology
Bachelor’s Degree, Mechanical Engineering
Wichita State University
Master of Science (M.S.), Mechanical Engineering
University of the Cumberlands
Executive MBA, Strategic Management
Indian School of Business
Technology Entrepreneurship Programme, Business Administration and Management, General
ABOUT RITHVIK V.
Experienced Senior Manufacturing Engineer with a proven track record in the medical device industry, specializing in process optimization, quality control, and project management. I have successfully led capacity expansion projects within the Suture Growth Initiative, integrating cutting-edge machinery for sutures welding, barbing, and packaging at the North Haven manufacturing plant. Previously, I contributed to the development and qualification of Continuous Glucose Monitoring products and processes as a Manufacturing Systems Engineer at Dexcom. My expertise includes the development and execution of comprehensive project plans, ensuring alignment with business objectives and adherence to timelines and quality standards. I am skilled in commissioning and validating automated systems. My background includes a Master of Science in Mechanical Engineering and ongoing pursuit of a Master of Business Administration. I am passionate about continuous improvement and leveraging Lean methodologies to enhance operational efficiency.
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