Profile Details

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★★★★★

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USD 125 /hr

★★★★★

☆☆☆☆☆

Hire Johannes e g Hans V.

Netherlands

USD 125 /hr

Global Expert in Quality engineering management, Auditing, and Regulatory Compliance, SQE. Delivering results for proces

Profile Summary

Eager to contribute with my passion for quality improvement, attention to detail, and auditing expertise, ensuring success process architecture works and regulatory compliance. With 25+ years of global experience in quality and regulatory management for complex medical and high-tech products, I’ve led audits, and contributed to post-market systems, and process improvements across major organizations like Olympus, Genpact, McKinsey, Philips, ASML, and Dekra, as well as various startups, gaining extensive international experience

Subject Matter Expertise

• ☆ Electrical Engineering
• ☆ Electronics Engineering
• ☆ Wireless Sensor Networks
• ☆ Software Engineering
• ☆ Internet of Things
• ☆ Software Architecture
• ☆ Systems Engineering
• ☆ Process Control
• ☆ Data Analysis
• ☆ Data Management
• ☆ Data Architecture
• ☆ Knowledge Management
• ☆ Information & Knowledge Management
• ☆ Running
• ☆ Cross Cultural Communication
• ☆ English as a Second Language (ESL)
• ☆ Teacher Education
• ☆ German
• ☆ Excel
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Wearable Technology
• ☆ Medical Device Prototyping
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Occupational Health & Safety
• ☆ Product Evaluation
• ☆ Material Sourcing
• ☆ Reverse Engineering
• ☆ Supply Chain & Logistics
• ☆ Inventory Control
• ☆ Shelf-Life Testing
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Product Compliance
• ☆ Concept Development
• ☆ Product Launch Support
• ☆ Software Development
• ☆ Software QA & Testing
• ☆ Feasibility Studies
• ☆ Gap Analysis
• ☆ Process Design
• ☆ Skills Training
• ☆ Regulatory Writing
• ☆ Nonclinical Study Documentation
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Technical & Scientific Writing
• ☆ Instructional Materials
• ☆ Release Notes
• ☆ SOP & Protocol Writing
• ☆ Case Studies
• ☆ Proofreading & Editing
• ☆ Language Translation
• ☆ Course Content Writing
• ☆ Consumer Products
• ☆ Business Strategy
• ☆ International Business
• ☆ Small Business
• ☆ Data-Driven Decision Making
• ☆ Entrepreneurship
• ☆ Environmental Law
• ☆ Medical Law
• ☆ International Law
• ☆ Innovation Management
• ☆ Management Information Systems
• ☆ Crisis Management & Emergency Preparedness
• ☆ Project Management
• ☆ Risk Management
• ☆ Six Sigma
• ☆ Management Consulting

Services

• Writing
• Consulting
• Product Development

Writing Medical Writing, Technical Writing

Consulting Go-to-Market Strategy Consulting, Digital Strategy Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Product Evaluation, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Product Launch Support, Device Fabrication

Work Experience

Consultant/Owner

Haveitmade Companies

May 2009 - Present

Owner Consultant

Haveitmade Companies

May 2009 - Present

Education

BSc Engineering

Fontys University

August 1984 - July 1989

Certifications

• Lead Auditor

  Theknowledgeacademy

  https://drive.google.com/file/d/1-CtVWuuMIsSPxl-_oGERx7rqYuN-OiF5/view?usp=drivesdk

  October 2024 - Present

Publications

BOOK

Hans van Leuven Did not write a Book . Myself.