With her pragmatic approach and clear attention to detail, Sharon is our Quality Manager specialising in ISO 13485, the mandatory Quality Management System for Medical Devices.
Sharon has over 12 years’ experience working within the ophthalmic and medical device industry ensuring that the rigorous operating procedures required under the relevant regulatory frameworks are adopted and fully adhered to throughout the entire lifecycle of the product development and production.
Sharon has developed Quality Management platforms on both ISO9001 and ISO13485; is an internal auditor for both standards and is fully experienced in MHRA and clinical trial studies.
We had a nice coffee break and got to ask Sharon some interesting questions. Read all about it below!
When did you get involved with Occuity? Why did you feel it was the right thing for you?
I worked with Dan and Robin before for 10 years at Lein. I have always been interested in the screening and monitoring of health conditions that was the core technologies that Lein had previously worked on so when they decided to start Occuity and asked for my help, I was glad to join.
What do you think about Occuity’s work so far?
Incredibly interesting work that has gown so quickly from an idea to design to product
What do you do and why is it important?
I specialise in quality management systems and have great attention to detail. I can manage the processes and the documentation chain of events ensuring that we produce a safe medical device to the market.
Which project/device most excites you and why?
Definitely the PM1 and the glucose project as I was involved in the original MHRA/ clinical studies back in 2010. To be able to see a product like this come to market and know that I was involved in its development is quite special.
How do you think will Occuity’s future look like?
I cannot wait to see how Occuity grows, the products, the team, the ideas are all so very exciting.