Over 10 years of experience in Post Market Surveillance, Medical Device Vigilance Reporting, EU MDR 2017/745 Remediation, Technical Documentation within the medical device industry and quality Assurance where customer focus, six sigma problem solving, continuous improvements & lean manufacturing in manufacturing industry.• Leading a team of 12 members for the PMS Complaint Handling Project focused on Intake and Closure for Becton, Dickinson.• Prepared SCAR (Supplier Corrective Action Request) documents to address supplier-related issues.• Conducted Medical Device EU MDR 2017/745 Gap Assessment & Remediation to ensure compliance with European Medical Device Regulations.• Performed Gap Assessments & Execution for ISO standards, including 15223-1, ISO 20417, ISO 14971, ISO 13485.• Prepared GSPR (General Safety and Performance Requirements) Checklists based on MDR Annex 1 & 2.• Managed Risk Management Execution & Assessment to identify and mitigate potential risks.• Handled CAPA processes using 8D methodology to address and resolve quality issues.• Applied Lean Six Sigma principles, FMEA (Failure Modes and Effects Analysis), APQP (Advanced Product Quality Planning), and PPAP (Production Part Approval Process) to optimize quality processes.•