Kevin Badin

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.

Linda Allwork

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.

Meet The Team

Keren Natalia

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..

Belinda Tupou

Marketing Project Manager

  • Founder of Mind My Marketing

  • NSW PRIA Council Member (Public Relations Institute of Australia) 

 

Belinda Tupou migrated from New Zealand to Australia in 1993. Belinda is a marketing professional with twenty years extensive experience in senior marketing and corporate affairs.

With demonstrated academic achievements in Marketing and Human Resources, Belinda holds a Bachelor of Business (marketing).

 

Founder of Mind My Marketing, she operates a boutique marketing business in Sydney Australia for various clients in diverse industries.

ORA innovations boasts over 30 years of combined experience in Quality Management Systems, Compliance, Project Engineering, Product Development, Auditing, Training, New Product Introduction, Documentation and Manufacturing for diverse industries from Electronic Equipment, to Medical Devices and Pharmaceuticals.

With a wealth of experience in Implementing, Auditing and Managing Quality Management Systems ORA innovations has led a number of Medical Devices Companies to achieve their certification to ISO13485, CE Mark their products and others to ISO 9001.

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