Profile Details

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Hire Iryna K.

Germany

USD 40 /hr

ISO Compliance & Quality Management Expert | Audits, Risk Management, Process Optimization Consultant

Profile Summary

I am a highly experienced consultant specializing in ISO compliance, quality management, and process optimization. With over 35 years in the industry, I have helped organizations streamline their operations, reduce risks, and ensure adherence to international standards. My expertise spans across ISO 9001, ISO 14001, ISO 27001, ISO 45001, and other quality management systems, providing businesses with the tools they need to improve efficiency and maintain compliance. I bring a deep understanding of quality assurance and audit practices, having worked with multinational companies to implement and oversee internal and external audits. Whether you need help with improving operational processes, preparing for certification, or managing quality control in complex environments, I can offer tailored solutions that meet your business objectives. I am committed to delivering results that drive sustainable growth, reduce operational risks, and ensure continuous improvement.

Subject Matter Expertise

• ☆ Industrial Engineering
• ☆ Industrial Operations Research
• ☆ Manufacturing
• ☆ Process Control
• ☆ Production & Operations Management
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Risk Management

Services

• Writing
• Research
• Consulting
• Product Development

Writing Non-Medical Regulatory Writing, Technical Writing

Research Technology Scouting

Consulting Business Strategy Consulting, Operations Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Formulation, Stability/Shelf Life Testing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Device Fabrication

Work Experience

Head of Quality Department

Military Tech/NDA

August 2023 - October 2024

Head of Standardization, Certification and Quality Department

Ajax Systems LLC

September 2016 - August 2023

Independent Technical Consultant

Independent Technical Consultant

January 2013 - September 2016

Director of Quality Assurance

Holding Company "Group NORD"

May 2011 - December 2013

Education

Master's degree

Donetsk National Technical University

September 1982 - June 1987

Certifications

• lSO 9оо1:2о15 Lead Auditor

  TÜV Nord

  May 2025 - Present

• Al For Everyone

  deeplearning.ai

  January 2025 - Present

• Information security management systems Specialist/ Internal Auditor of ISO/IEC 27001

  IMS Academy

  July 2023 - Present

• Internal auditor of integrated management system of ISO 9001, ISO 14001, ISO 45001

  INTERSERT-UKRAINE LLC

  December 2020 - Present

• Lean. Lean tools

  Центр бизнес-технологий ТОТ

  August 2018 - Present

• Internal auditor of systems management ISO 9001

  INTERSERT-UKRAINE LLC

  April 2018 - Present

• Quality Management Systems and Internal Audit

  Академия "Прирост"

  May 2012 - Present