Brijesh Chaudhari

About Brijesh Chaudhari

Having 3 years of diagnostic X-ray equpment complaint handling experience with 95% FTR accuracy and Zero audit findings.Having 6+years of experience in Quality assurance and Regulatory affairs for diagnostic x-ray equipments like CT scan cathlab conventional x-ray fluoroscopy cbct mammography iopa etc.Certified RSO from AERB and having regulatory compliance with respect to AERB for diagnostic x-ray equipments.Having experience in ISO 13485 for medical devices and diagnostic x-ray equipments.Having experience into medical devices labeling as per iso 15223: 2017.Having experience into NABL ISO/ IEC 17025:2017.S.O.P. F.R.C. QA QC DOCUMENTATION Having service experience in medical equipments like lithotripsy laser ultrasound lithoclast equipment. served as a RSO for more than 5 years.

Experience

1. Global Complaint Handling Specialist

   Philips

   May 2023 — Present · Pune, IN

   Global Complaint Handling Specialist – Image Guided Therapy & Medical Devices (X-ray)Philips HIC-Customer Complaint Resolution: Handled 1,700+ complaints and feedback in Trackwise tool, achieving 95% backlog reduction and maintaining a 95% first time-right resolution rate under pressure-Regulatory Compliance: Led a team of 4 in managing Accidental Radiation Occurrence (ARO) cases (2024–25), ensuring accurate quarterly reporting to the FDA-Quality Improvement Leadership: Directed a team of 4 under a structured Quality Improvement Program, delivering measurable enhancements in product and process quality-Critical Investigations: Investigated death and serious injury complaints with proactive, cross-functional collaboration (CAPA, Risk Management, R&D, FSE/RSE, Technical teams, Clinical experts)-CAPA Implementation: Successfully initiated and executed CAPA actions addressing root causes of ARO cases, strengthening compliance and patient safety-Audit Excellence: Maintained zero audit findings, setting a benchmark for high-standard recordkeeping and serving as a role model in quality investigations-Gap Identification: Proactively identified quality gaps, aligned teams on corrective actions, and ensured continuous improvement-Leadership Growth: Progressed from team member to dependable internal team lead, demonstrating adaptability, accountability, and strong leadership-Technical Expertise: Performed log file analysis to determine potential root causes, driving investigations to clear and actionable conclusions.

Education

• Watumall Institute of Electronic Engineering and Computer Technology Plot No.47 R.G. Thadani Marg Worli Sea Face Mumbai 400 018

  Bachelor of Engineering - BE, Bioengineering and Biomedical Engineering

  2009 — 2014

• University of Mumbai

  Bachelor's degree, Biomedical/Medical Engineering