Naveen Kumar

• Preparation of Testing protocols Tools
• Preparation of Verification analysis report
• Supporting Various R&D documents and Responsible for the execution and completion of assigned Design controlled projects
• Ensuring that all necessary cross-function teams have visibility to all activities associated with the project.
• Coordinating with various teams for achieving delivery targets (R&D, QA, RA Review meeting).
• Check and verify the functional test reports in DHF folders

• Intake, processing of complaints in the application, and follow-up for the required data for complaint intake and investigation.
• Investigating and Failure analysis of recalled products and devices, identifying the root cause and analyzing CAPA, Codes of failure.
• Managing and monitoring medical device Complaints & reporting on adverse events and Malfunction.
• Performing follow-up with customers/complainants for required additional information.
• Working on multiple phases of Complaint handling such as Complaint remediation, MDR (Medical Device Reporting) & Quality for Infusion pump modules.
• Review complaint records and apply standard operating procedures to determine MDR Reportability by 21 CFR 803 and create the eMDR to submit to the FDA.
• Good Knowledge of 21 CFR 820, and 21 CFR 803

• Detailed Gap Analysis on MDR Labeling part for MDR and remediating the labels
• Perform labeling verification study, Labeling verification protocol, and report creation.
• Performing the activity of MLGA (Master Level Gap Analysis) for Medical device Labels
• Preparation of Redline and Evidence Markup for labeling and packaging.
• Interacting with the client regarding labeling requirements

• Creation of Risk Management documents such as RMP, DFMEA, and RMR
• Remediation of documents like GSPR, Verification and Validation report
• Analyzing MDR Gaps
• Defect-free deliverables
• Client interaction regarding process requirements

• Identifying reliable products with competitive cost. Development of the existing or new customers & new programs.
• Expertise in the development of fuel injection equipment and calibration for petrol and diesel engines
• Knowledge of working in automation test cells like DAQ and Pisnoop and analyzing turbocharged engines, internal and external EGR systems
• Knowledge of working in automation test cells like iAsys, Dynalec
• Performing the vehicle testing on Road for two-wheeler and acquiring the data