Keyur Zanzmera

About Keyur Zanzmera

Advance Quality Assurance Engineer with extensive experience in Software Verification & Validation (V&V), Software Development Life Cycle (SDLC) processes, and Computer System Validation (CSV). Experienced in designing, executing, and managing comprehensive test plans, validation protocols, and traceability matrices to fully comply with regulatory standards such as ISO 14971, ISO 13485, IEC 62304, and FDA requirements.Proficient in applying SDLC best practices to integrate quality assurance early and throughout the software development process, enabling proactive identification and resolution of defects. Skilled in risk management through root cause analysis, CAPA, and complaint handling to mitigate high-impact issues and ensure patient safety.Experienced in maintaining and auditing Quality Management Systems (QMS) to align software validation and testing activities with regulatory expectations and continuous improvement efforts. Collaborative in working across R&D, regulatory, and operations teams to deliver reliable, audit-ready software solutions that support critical medical device functions and enhance clinical outcomes.

Experience

1. Senior Advance Quality Engineer

   Stryker

   Mar 2026 — Present · Gurugram, IN

Education

• SRM IST Chennai

  Master of Technology - MTech, Biomedical Engineering

• Government Engineering College,Gandhinagar

  Bachelor of Engineering, Bio-Medical Engineer