Ramkumar Karlapudi

Global Complaint handling Specialist with 11+ years of experience in medical devices and having experience in the complaint handling process, Post-marketing surveillance, and sustenance engineering. Having good knowledge of Packaging design and development using Auto-CAD and Solid Works.

• Father's Name: Krishna K (Late)
• Mother's Name: Aparanji K
• Gender: Male
• Nationality: Indian
• Marital Status: Single

• Revvity Healthcare India Pvt Ltd, Global complaint handling Specialist (Production & Quality), Investigated customer complaints, conducted root cause analysis, and developed corrective actions (CAPA)., Responsibility for conducting Senior Management Review Meeting for the Projects every month., Preparing & Monitoring Project Initiation, Planning, Execution, and Closure quality documents., Conducting daily and weekly meetings for solving the daily issues and queries, regularly and progressing the high TAT complaints moved to closed status without any escalation., Handling customer complaints and failure analysis of the complaint or warranty claim parts by establishing corrective and preventive action., Responsible for complying with requirements for the Product Development Process (PDP), Risk Management, and Design Controls of Medical Devices as per FDA 21 CFR Part 820, ISO 13485 & MDD.
• HCL Technologies, Technical Lead (Production & Quality), Responsible for complying with requirements for the Product Development Process (PDP), Risk Management, and Design Controls of Medical Devices as per FDA 21 CFR Part 820, ISO 13485 & MDD., Preparing & Monitoring Project Initiation, Planning, Execution, and Closure quality documents., Responsibility for conducting meetings with the onsite team, offshore team & client., Responsibility for conducting Senior Management Review Meeting for the Projects every month., Conducting daily and weekly meetings for solving the daily issues and queries, regularly and progressing the high TAT complaints moved to closed status without any escalation., Handling customer complaints and failure analysis of the complaint or warranty claim parts by establishing corrective and preventive action., Investigated customer complaints, conducted root cause analysis, and developed corrective actions (CAPA).
• ATOS Syntel Pvt Ltd, Associate Consultant (Production & Quality), Investigated customer complaints, conducted root cause analysis, and developed corrective actions., Act as a team leader for label creation projects and have good knowledge of Label creation, template creation, UDI grading, and IFU creation for Medical Devices., Having a sound knowledge of the creation UPDDs, UPADs and SBADs, Cartons, pouches, and Spacer drawings for a packaging design for medical device products., Experienced in Change control management and its entire process from change initiation to change closure using a dedicated client tool., Having good knowledge of packaging materials like Foils, Overwrap, and carton materials., Expertise in handling the label creation tools like Enlabel tool, and IPM tool for the creation of mass production labels., Administration of engineering work orders, which implement changes to production parts., Developing prototypes, Assembly, and packaging work instructions
• Collabera Technologies, Sr. Associate (Production), Responsible for Preparation of Design control like Design Input, Design Output, Design Transfer, Verification & Validation documents., Good understanding of regulatory guidelines and standards, right interpretation, and implementation of the same in actual practice. Performing Gap Analysis & Remediation of legacy medical devices by DHF according to MDR requirements, process, standards, and customer requirements., Project Planning, Estimation, onsite-offshore meeting, Review, weekly client interaction, Monitoring & tracking each task, and providing training to the team members., Good knowledge of Product Lifecycle Management (PLM), DMR/DHF Documents, CCM, Risk assessment.
• Source One Management Services, Associate (Production), Converting 2D drawings into 3D models using Creo 2.0, Documentation and detailing of Medical Equipment (Implant, Instruments, Power Tools) for the Sterilization process., Preparing Disassemble & Assemble Instruction (DAI) for various Medical Equipment. Responsible for the concept design & 3D modeling., Responsible for preparation of Bill of material., Assist in project planning and provide mechanical design leadership in project execution., Analyze and perform quantitative assessment of design prototypes in line with regulatory and industry norms to tackle all regulatory and marketing issues., Prepare test documents and presentation materials., Review product documentation for accuracy including documentation intended for customer use., Expertise in using MS-Office tools especially advanced Excel tools (Macros, Pivot Table)
• Hamsa Minerals India Private Limited, Assistant Mechanical Engineer (Production & Maintenance), Preparing the daily/Monthly reports of the Heavy Machinery Vehicles (L&T Komatsu, CAT, and Sandvik), Preparing 2D drawings by using Auto-CAD Tool and Making sure all safety precautions are taken., Carried out safety tests and recorded results on mechanical equipment and systems and recommended improvements., Responsible for the plant and equipment maintenance and replacement of worn-out parts., Close interaction with Chinese Dealers and making the Purchase order for required Machined parts., Expertise in using MS-Office tools especially advanced Excel tools (Macros, Pivot Table).