プロフィール詳細

プロジェクトを作成

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Woodrow S.に依頼

United States

Medical Device Quality & Regulatory Consultant; ISO xxxxxxxxxx, FDA, MDSAP, EU MDR Compliance

プロフィール概要

I am a Certified Quality Engineer and ISO 13485-trained Lead Auditor with a background in biomedical engineering and hands-on experience leading validation, compliance, and regulatory activities for medical device manufacturers. I help startups and small companies implement lean, audit-ready quality systems, prepare successful regulatory documentation, and validate processes and test methods. I started my professional career as an officer in the U.S. Marine Corps, bringing strong leadership, discipline and attention to detail to every project. My past roles include managing 510(k) submissions, leading design, process and test method validations, developing and implementing complaint handling and supplier management systems, and preparing companies for ISO and regulatory audits. I have extensive experience in root cause analysis and owning the CAPA process from problem identification to verifying the effectiveness of corrective actions. Whether you are a medical device manufacturer looking for targeted compliance solutions or a supplier of a medical device manufacturer navigating QMS requirements for the first time, I can help you achieve your QMS goals. My mission is to help the next generation of medical device innovators bring safe and effective products to market in the most efficient manners possible.

専門分野

• ★ ISO 13485
• ★ ISO 14971
• ★ SOP & Protocol Writing
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Validation
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Clinical Evaluation Reports (CER)
• ☆ Premarket Notification/510(k) Submission
• ☆ Technical & Scientific Writing
• ☆ Experimental Protocols

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Technical Writing

Research Gap Analysis

Consulting Go-to-Market Strategy Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Statistical Analysis, Data Visualization

Product Development Stability/Shelf Life Testing, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Prototyping

職務経験

Quality Engineer

NovaBone Products, LLC

1月 2024 - 現在

Quality Engineer

Zimmer Biomet

5月 2023 - 11月 2023

Quality Engineer

Myolyn, Inc.

8月 2021 - 5月 2023

QUALITY INSPECTOR

Winco, mfg

1月 2021 - 8月 2021

学歴

Biomedical Engineering

Florida International University

6月 2012 - 5月 2017

認定資格

• Certified Quality Engineer

  American Society for Quality

  https://credentials.asq.org/7b0cba0e-9549-42e6-8f98-13bf12c01063#acc.jx0gqki8

  4月 2025 - 現在

• Lean Six Sigma Green Belt

  University of Central Florida

  12月 2021 - 現在