About QA&C Consulting

Medical Device QA and Regulatory Consulting expertise

My name is Dimitri Leo. I am an accredited Quality Practitioner (PCQI, CQA), certified Project Manager (MPM, CIPM), and qualified Engineer (MEng, IEAus) with over 20 years of professional experience dedicated to Quality Management.

Throughout my career, I have observed a recurring pattern across companies of all sizes: Quality Assurance was often treated as an afterthought. It was reactive, under-resourced, and misaligned with the development lifecycle. With decades of hands-on experience in QA strategy, and leading quality teams, I knew there had to be a better way.

With a Master's degree in Engineering and a PhD research background, I bring a strong academic foundation to my work. Supported by Project Management certification and formal QA qualifications, I am able to bridge complex technical requirements with broader operational and business objectives.

Throughout my career, I have worked across diverse industries, including civil aviation, RF and GPS navigation systems, IT, mining, and most extensively medical devices design and manufacturing. In these sectors, I have led cross-functional engineering and quality initiatives as a practising QA auditor and ISO 9001 consultant, driving product design and development, manufacturing excellence, QA/QC processes, and regulatory compliance.

Founder Story

Dimitri Leo

MEng, IEAus, PhD, MPM, CIPM, LSSGB, GMP, PCQI, CQA

QA&C Consulting™ 2025

ABN: 42155766734

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