Yaswanth Kumar Email & Phone Number

Hyderabad, In

Madurai, Tamil Nadu, India

• Gather initial information on medical device complaints from various sources, track, follow - up and update complaints data using BDX Track-Wise Tool.• Follow up with customers to gather additional information to achieve Good Faith Effort (GFE) andInvestigate customer complaints related to medical devices.• Submit Adverse Event and Product Malfunction reports to FDA (21 CFR 803) and Health Canadafollowing defined SLAs and SOPs for Legacy and 510K approved Devices.• Acting… Show more • Gather initial information on medical device complaints from various sources, track, follow - up and update complaints data using BDX Track-Wise Tool.• Follow up with customers to gather additional information to achieve Good Faith Effort (GFE) andInvestigate customer complaints related to medical devices.• Submit Adverse Event and Product Malfunction reports to FDA (21 CFR 803) and Health Canadafollowing defined SLAs and SOPs for Legacy and 510K approved Devices.• Acting as an SME for updating and submitting MedWatch complaints and peer reviewed processed complaints and reduced errors for the project and supported auditor during internal Audits.• Performing Complaint Trend Reporting. Identifying device non-conformities and Initiating SCAR/ CAPA for Out of Box Failures for Post 510K approved devices.• Ensuring all documents in use are latest versions and established SharePoint path to ensure all theversions of documents stored and routed by DocuSign and SAP - Tahiti.• Created Enhanced Mass Upload Automation Tool involves Data prepping and QC for electronicsubmission of Medical Device Reports to USFDA which reduced TAT and Late MDRs. Show less

Hyderabad, Telangana, India

1. Design, model, and test prototypes for products.2. Conduct research and create design proposals 3. Create concepts, performance, and production criteria.4. Identify and select materials needed for production.5. Produce final hand drawings and specifications. Create parts lists.6. List costs involved in production.7. Plan marketing initiatives for product.8. Negotiate appropriate production processes.9. Use computer-aided design (CAD) and Solid-works to… Show more 1. Design, model, and test prototypes for products.2. Conduct research and create design proposals 3. Create concepts, performance, and production criteria.4. Identify and select materials needed for production.5. Produce final hand drawings and specifications. Create parts lists.6. List costs involved in production.7. Plan marketing initiatives for product.8. Negotiate appropriate production processes.9. Use computer-aided design (CAD) and Solid-works to design concepts.10. Monitor and perform quality trend analysis;11. Document process deviation and share it with the analysts, team leads, and manager on a weekly/monthly basis.12. Assist in optimizing Quality Control data dashboards for key findings Show less

Hyderabad, Telangana, India

Graduate Trainee at Naresh i Technologies in SQL Server Database Management.