Oli Biswas

Background

About Oli Biswas

I am an enthusiastic and resourceful professional. Some of my responsibilities are 1. Implement quality management and quality control for the organization as per ISO 13485:2016, ISO 9001:2015, EU 2017/746 IVDR, ICMED 13485 2. Managing Internal Audit, External Audit, and Regulatory Audit 3. Managing operational aspects of different projects and programs by ensuring that all project work is completed in accordance with SOP. Determining, negotiating, and agreeing on in-house quality procedures, standards, and specifications 5. Perform systematic and independent examination of all activities and documents, to determine whether the evaluated activities were appropriately conducted and the data were generated, recorded and analyzed and accurately reported according to the protocol and SOP 6. Conduct periodic operational checks within each functional department to ensure overall quality 7. Develop the organizational structure, responsibilities, procedures, process, standards and specifications