Nirav Soni

Background

About Nirav Soni

Strategic Quality Engineering Leader with 18+ years of experience driving operational efficiency, team development, and cross-functional collaboration in the Life Sciences, Medical Device, Biotechnology and Pharmaceutical industries. I partner with organizations to strengthen quality systems, ensure regulatory compliance, and drive operational excellence. As a consultant, I combine deep technical expertise with leadership skills to guide teams, mentor stakeholders, and deliver practical, sustainable solutions.Key Competencies- Strategic Leadership & Team Development- Quality System Engineering- Risk Management (ISO 14971/ TR 24971)- Cross-functional Collaboration & Project Management- Product Development Life Cycle Management- New Product Introduction - ISO 13485 | FDA Regulations (21 CFR 820)- Sampling Standards (ANSI Z1.4/ANSI Z1.9)- Verification and Validation - Project ManagementMy leadership approach fosters innovation, collaboration, and measurable improvements, consistently delivering results aligned with the highest industry standards. I focus on empowering client teams, providing actionable insights, and aligning quality practices with business goals. My approach balances compliance, efficiency, and innovation to help organizations achieve measurable improvements while fostering a culture of accountability and collaboration.