Sri Kumar

About Sri Kumar

Experience in drafting and reviewing Post Market Surveillance and Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), Clinical Development Plans (CDP), Periodic Safety Update Reports (PSUR), PMS Plan, Post-Market Clinical Follow-Up Plans (PMCF), and Summary of Safety and Clinical Performance (SSCP) for Class I, Class IIa, Class IIb, Class and Class implantable medical devices.

Experience

1. Senior Quality Engineer

   Stryker

   Sep 2025 — Present · Gurugram, IN

   Responsible for drafting and reviewing of Post-Market surveillance (PSUR, PMS Plan, PMCF Plan and Reports, HCSR) and clinical documents.• Investigates & document customer complaints according to applicable regulatory requirements and products.• Complete complaint investigation templates.• Performs collective analyses of product complaints and reports for trends and identification of potential corrective or preventive actions• Ensures timely investigation of and response to product complaints. This involves initiating and participating in investigations and corrective action arising from product complaints.• Work closely with stakeholders & team individuals and provides, direction & coaching to drive team engagement.• Collect inputs from all stakeholders & team members and use project management practices to monitor and control the progress of the project. • Responsible for the timely and quality deliveries from the team.

Education

• Anna University

  Be Biomedical Engineering

  2018 — 2022