ARUNDEV SU

Project: Boston Scientific – Design Quality Assurance - DQA (Medical Devices)

• Urology Product Sustenance Activity
• Design Change Analysis
• DFMEA and Task Analysis
• Risk Analysis/Assessment
• Post market surveillance activities (PMS,PSUR)
• Complaint Assessment
• Process Improvement Projects
• Team Management

Project: Becton and Dickinson (BD) - Quality & Regulatory compliance (Medical Devices)

• Customer complaint investigation process for medical devices, Investigation, RCA(Root Cause Analysis), and Report Submitting & Completion in TrackWise
• MDR and IVDR - Remediation [including preparation of product-specific Technical documentation/STeDs, GSPR, and PER (Performance Evaluation Reports) Kits] to comply with the latest regulation and review
• The investigation, CAPA, Change management process Risk management (Risk management plan, Risk management File) review
• Internal Audit- Plan, Execution & Closure
• Review of Global procedures & Implementation of Global documents to the sites and report monthly quality metrics

Project: Johnson and Johnson consumer source quality

• Supplier Audit for New Supplier Qualification and Periodic audit (Remote Desktop Audit/Virtual Audit)
• Supplier Management
• Quality Requirement Activity and Internal Assessment
• Auditee Information Management Creation, Updating, and Gap analysis in Track Wise
• Performing Creation, Execution, and Deliverables activity performing for Global Change Control
• Supplier Risk Assessment and Mitigation

• Building and Implementation of the quality management system as per ISO 13485 and controlling and maintenance of the documentation system
• Conducting and Analysis of Incoming, In the process, and final products as per the SOP
• Preparation of SOP, Documents, Forms, and periodic review
• Conducting internal Audits, Risk Analysis, and Training
• FMEA Analysis for the product and process improvement
• Worked on Building and Implementing Quality Management System and successfully obtained ISO 13485:2016 Certification

• Analysis of Finished Products (API-Small molecules) Statin drugs and immunosuppressants
• QC Analysis by using Analytical instruments (HPLC, GC, FTIR, UV Spectrometer, Etc)
• Reviewing of Quality reports
• Handling of Laboratory incidents and investigation of Out of Specifications
• Improvement in the Quality department and Audit compliance
• Implemented better documentation practices to reduce the product approval time from Quality