Profile Details

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Hire Anil I.

India

USD 45 /hr

Medical Device Quality & Regulatory Specialist | ISO 13485 | EU MDR | CAPA | Validation

Profile Summary

I am a Medical Device Quality, Regulatory, and Validation Specialist with 8+ years of experience at Philips, Johnson & Johnson, Medtronic, and Flex. I help companies achieve ISO 13485 compliance, prepare EU MDR documentation, resolve CAPA/NCR issues, and create audit-ready validation and technical documents. Expertise: ISO 13485 QMS documentation (SOPs, WI, templates) EU MDR Annex II & III technical documentation Risk management (ISO 14971, DFMEA, PFMEA, hazard analysis) CAPA investigations and remediation Process validation (IQ/OQ/PQ) Computer System Validation (CSV) – SAP, TrackWise, Salesforce Test Method Validation (TMV) DHF/DMR/DHR creation and cleanup Technical writing for medical device companies I deliver accurate, compliant, and audit-ready documentation with fast turnaround times.

Subject Matter Expertise

• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Validation
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Risk Management

Services

• Writing
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing

Consulting Healthcare Consulting, Operations Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Stability/Shelf Life Testing, Material Sourcing, Product Validation, Quality Assurance & Control (QA/QC), Product Compliance , Packaging Design, Reverse Engineering, Device Fabrication

Work Experience

Supplier Quality Engineering Lead - Manufacturing Transfer

Philips Healthcare

August 2023 - October 2024

Project Engineering Team Lead - EU MDR & CAPA Remediation

Johnson and Johnson

December 2021 - July 2023

Sr. Quality Engineer - New Product Introduction / CSV

Flextronics

May 2021 - December 2021

Supplier Quality Engineer -Manufacturing Transfer

Medtronic

August 2017 - April 2021

Education

Ms in engineering technology

University of North Texas

August 2015 - May 2017

Certifications

• masters in engineering technology

  UNIVERSITY OF NORTH TEXAS

  May 2017 - Present