Oviyaasri Manimuthukumar

Conducted comprehensive process audits to ensure adherence to ISO 13485 and GMP standards, implementing quality assurance controls. Utilized Exact for streamlined quality management, contributing to efficient resolution of quality-related issues. Developed a KAIZEN APP using Power App and Python. Streamlined CAPA processes, resulting in an 80% reduction in corrective action cycle time. Conducted FMEA analysis, leading to a 70% decrease in product failure rates.

Managed a team of Production operators, providing leadership, guidance, and training in medical device manufacturing processes. Conducted comprehensive machine validation processes before machine operation, ensuring reliability and compliance with regulatory requirements. Conducted meticulous quality inspections using specialized equipment for delicate medical product assembly, ensuring compliance. Proficiently utilized SAP ERP for effective inventory and transportation management.