Open to opportunities

HUW williams

@huwwilliams

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Experienced Internal Auditor and Quality Assurance Professional with 15+ years.

United Kingdom

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What I'm looking for

I am seeking a role that values regulatory excellence and offers opportunities for professional growth.

I am an experienced Internal Auditor and Quality Assurance Professional with over 15 years of expertise across various sectors, including legal, medical devices, defense, and software. My qualifications as a Lead Auditor (ISO 13485) and my proficiency in ISO 9001, EU MDR, and UK MDR frameworks have equipped me to manage risk-based audit programs effectively. I have a proven track record in CAPA processes and continuous improvement initiatives, which have significantly enhanced regulatory compliance and operational efficiency.

Throughout my career, I have demonstrated my ability to collaborate cross-functionally, train and mentor teams, and drive regulatory excellence. My analytical mindset and adaptability have allowed me to develop integrated audit and risk frameworks, ensuring that organizations not only meet compliance standards but also foster a culture of continuous improvement. I take pride in my achievements, including training over 100 professionals in compliance and audit readiness and receiving commendations for my contributions to systems integration.

Experience

Work history, roles, and key accomplishments

Current

Quality Auditor

Current

Hugh James Solicitors

Jun 2024 - Present (1 year 4 months)

Led internal audits against ISO 9001, 14001, SRA, and Lexcel standards. Managed the internal audit program and CAPA register, while also training legal professionals on compliance.

ISO 9001 ISO 14001 SRA Lexcel CAPA Audit Management Training Risk Management GDPR

Quality Engineer (QMS)

Neogenomics

Apr 2022 - Sep 2024 (2 years 5 months)

Served as Lead Auditor for ISO 13485 certification audits, significantly improving CAPA and Change Management processes. Oversaw comprehensive document control and QMS updates to maintain high standards.

ISO 13485 CAPA Change Management Document Control Auditing Certification Documents

Internal Auditor

NEC Software Solutions

Dec 2023 - Apr 2024 (4 months)

Delivered ISO 13485, 14001, and 27001 audits for medical AI software platforms, ensuring MDR and ISO 13485 compliance. Managed cross-functional collaboration between QA, Regulatory, and software development teams.

ISO 13485 ISO 14001 ISO 27001 Cross Functional Collaboration Quality Assurance Regulatory Compliance Software Development

NPI Quality Engineer

Creo Medical

Oct 2021 - Mar 2022 (5 months)

Led validation processes for electrosurgical IR/UV device development, ensuring compliance with ISO 13485 and ISO 9001 standards. Supported verification activities to meet regulatory requirements.

Validation ISO 13485 ISO 9001 Verification)Regulatory Compliance Medical Devices Verification

Regulatory Officer

Williams Medical Services

Jun 2021 - Sep 2021 (3 months)

Conducted internal and external audits in accordance with ISO 13485 and MDR standards. Strengthened risk management and technical documentation practices to enhance compliance.

Internal Audit Externe Audits ISO 13485 Risk Management Technical Documentation Compliance