QA&C Consulting™ was established in Australia to leverage over 20 years of my professional experience in Quality Assurance and Quality Control management across multiple highly regulated industries, including medical device design and manufacturing, rail, and mining.
Accredited as a Quality Practitioner (PCQI) by the Chartered Quality Institute (CQI) and Certified Quality Auditor (CQA), I bring internationally recognised quality expertise to QA&C Consulting™.
In my work I prioritise efficiency and effectiveness, wasting no time on idle conversations or over-utilising valuable resources, focusing exclusively on delivering fully compliant, functional, and customised Quality Management Systems specifically tailored to each client’s operational requirements at competitive and sustainable rates. Holding multiple internationally recognised certifications and professional qualifications, I currently provide specialised consulting services primarily to medical device manufacturers in the following areas:
Auditing established QMS for ISO 9001:2015 compliance
Building QMS from ground up for small businesses and start ups
Risk Management Framework ISO 31000, ISO 14971
Medical device SW development IEC 62304
Production part approval process (PPAP)
Supplier Audit Management Framework
Verification and Validation (V&V) to FDA requirements
Product Development Framework for medical device class 1,2,3
Manufacturing to ISO 13485 requirements
Change Management
Project Management
About QA&C Consulting
Medical Device QA and Regulatory Consulting expertise
My name is Dimitri Leo. I am accredited Quality Practitioner (PCQI,CQA), certifiedProject 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
