Meet The Team
Founder | QMS & Regulatory Affairs Consultant
BEng, MSc, AIMM
ORA innovations Principal
Kevin has over 20 years experience in Quality Management Systems, Compliance, Project Engineering, Product Development, Auditing, Training, New Product Introduction, Documentation and Manufacturing at very diverse industries from Electronic Equipment, VIP Jewellery and Defence Systems to Medical Devices and Pharmaceuticals.
Kevin possesses a wealth of experience in Implementing, Auditing and Managing Quality Management Systems where he led a number of Medical Devices Companies to achieve their certification to ISO13485, CE Mark their products and others to ISO 9001.
Kevin’s qualifications include a Masters in Engineering Projects Management, a degree in Industrial–Mechanical Engineering, a Certificate IV in Workplace Safety (WH&S) and a Certificate IV in Assessment & Workplace Training and more than 16 short courses on various topics. Kevin has been an active member of the Australian Institute of Management (AIM) for 15 years. Kevin is also a Life Coach.
Senior Quality Consultant
Linda is ORA innovation’s Quality Consultant of almost 5 years. She is a certified auditor for ISO 13485 and ISO 9001.
Her previous corporate roles include Industrial Engineer in the international freight industry; and an I.T. Project Manager in software engineering, development and Quality Assurance.
When not assessing certification processes for clients, Linda is also passionate in her role as a certified Cycling Coach for the oldest cycling club in Sydney.
Senior QA/RA Consultant
Ben comes with 20 years experience in QA and Regulatory Affairs in both the manufacturing medical devices and service sectors.
Needless to say – he has significant experience in setting-up, implementation, audit and managing Quality, OH&S and Environmental Management Systems in ANZ, Asia Pacific, Africa and Middle East. He is well versed in ISO13485, ISO9001, ISO14001 and ISO45001.
Ben holds a Masters degree in Engineering Management, Bachelors Degree in Electronics and Communication Engineering, Post-graduate Diploma in Quality Systems and International Diploma in Occupational Health and Safety Systems.
Marketing Project Manager
Founder of Mind My Marketing
Marketing Manager for Hylec Controls (medical test equipment suppliers)
Belinda Tupou migrated from New Zealand to Australia in 1993. Belinda is a marketing professional with more than 20yrs extensive experience in senior marketing and corporate affairs.
With demonstrated academic achievements in Marketing and Human Resources, Belinda holds a Bachelor of Business (marketing) and currently studying her MBA.
Founder of Mind My Marketing, she also operates a boutique marketing business in Sydney Australia for various clients in diverse industries.
Senior QA/RA Consultant
Keren has over 10 years experience in medical device and quality.
She has held various roles both in technical and managerial capabilities across a wide variety of device company ranging from small start-ups to global medical device companies.
She has extensive experience working with GMP certified facility, Class I-III Medical Devices, IVDs, Telehealth and Sterilisation units.