Profile Details

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Hire Kathleen D.

United States

USD 100 /hr

QMS Enthusiast | 16+ Years Experience in Broad-Ranging Compliance Support

Profile Summary

👩🏻‍💼 Who I Am: Seasoned QMS and Compliance consultant dedicated to helping organizations achieve operational excellence and regulatory success. With 16+ yrs of experience, I specialize in delivering tailored solutions that drive compliance, efficiency, and growth. 💼 What I Do: I partner with businesses to build robust Quality Management Systems (QMS), streamline processes, and ensure regulatory alignment. My services include: 🔹QMS Development: Designing and implementing ISO-compliant and FDA-ready systems customized to your needs. 🔹Internal Audits: Conducting thorough audits to identify gaps and ensure audit-readiness. 🔹CAPA Remediation: Resolving corrective and preventive action challenges with precision and speed. 🔹Risk Management: Developing risk-based strategies to mitigate threats and enhance decision-making. 🔹Cybersecurity Development Framework: “Baked-In” compliance and risk management in both pre- and post-market lifecycle stages for cyber devices. 🔹Supplier Management: Optimizing supplier relationships to ensure quality and compliance. 🔹Special Projects: Tackling unique challenges with innovative, results-driven solutions. 🔹Fractional Compliance Support: Providing flexible, on-demand expertise to scale with your needs. 🤝 Why Work With Me? I bring a hands-on, collaborative approach, combining deep regulatory knowledge (e.g., ISO 13485, FDA 21 CFR Part 820, MDSAP, EU MDR) with practical strategies that deliver measurable results, ensure compliance, and save time & resources. 📋 My Mission: To empower your team with systems and insights that not only meet regulatory standards but also drive business success. Whether you're a startup looking for your “compliance beacon” or an established company navigating more complex compliance needs, I’m here to simplify the process and deliver results. 📩 Ready to elevate your quality and compliance game? Let’s connect! Message me to discuss how I can support your next project.

Subject Matter Expertise

• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Medical Device Manufacturing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Medical Equipment & Supplies

Services

• Writing
• Consulting

Writing Non-Medical Regulatory Writing

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting

Work Experience

Founder and Principal Consultant

Durkin Quality Consulting, LLC

April 2025 - Present

Manager, Quality Assurance

Perimeter Medical Imaging AI

May 2021 - April 2025

Manager, Global QMS, Special Projects

LivaNova, PLC

August 2015 - May 2021

Quality Assurance Specialist

Cerilliant

May 2009 - August 2015

Education

BS Biology

Texas State University

January 1998 - December 1999

Certifications

• Lead Auditor Training

  AQS Management Systems, Inc.

  November 2015 - November 2018