Usman Mohammed

About Usman Mohammed

I am an experienced Biomedical Engineer with Regulatory Affairs and Quality Assurance experience with a demonstrated history of working in the medical device industry for 5 years in Individual Case Study Report (ICSR) processing, Team Handling, Workflow Management, Root Cause Analysis (RCA) investigation, CAPA and deviation filing. I have started my career as a Biomedical Engineer in 2016 and I have come across different types of spontaneous and solicited cases. As a case processor I have experience in end-to-end case processing of an ICSR which involves Triage, Data entry, MedDRA coding, Labeling, Narrative writing, Quality review and Submission on drug safety databases. I am also skilled in Python, Digital Marketing, Microsoft Office applications, Medical Devices etc.

Experience

1. Quality Assurance Associate

   Wipro

   Sep 2021 — Present · Kolkata, IN

   I have worked at Wipro as a Quality Analyst as well as a Quality Reviewer for Philips NAM and Galileo project, specializing in the post market surveillance of MRI medical device. During my time as a QA and QR at Wipro, I have done the reviewing and evaluation of complaints, Identification and documentation of serious/non-serious incidents, Reviewing of received medical recordings, Investigation and reporting of complaints to the regulatory authorities and determination and initiation of corrections and CAPAs.

Education

• Noorul Islam College of Engineering

  Bachelor's degree, Biomedical/Medical Engineering, 82%

  2012 — 2016