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Meet the team at Cambridge Design Partnership – a brief profile of the experts, engineers and interesting people that work here. This month we’re talking to Helen Simons, our medical devices quality expert, who’s been with the company for around 6 months.
Why did you join Cambridge Design Partnership?
From having worked at a consultancy before, I knew that the variety of work would lead to something new every day, and that aspect always appealed to me. I’d been aware of CDP for a few years – and then discovered on meeting the team that the company has a friendly and collaborative culture, where people are open and share interesting ideas.
What background do you come from and how do you apply this knowledge to your current role?
I got my MEng in Mechanical and Aeronautical Engineering at Durham, and this background has given me the ability in my career as a project manager and subsequently as a quality manager to speak to and understand the issues that engineers face. I can put things in context and help overcome barriers.
Initially after graduating I worked at a food preparation processing equipment manufacturer – I have the dubious accolade of having designed a conveyor belt for catching Pot Noodles if they fell off the production line!
I first got involved in quality at another consultancy, where I initially managed several medical projects but moved onto working with the quality manager to help implement and improve the quality management system (QMS) there. After that, I worked as quality manager for a haircare manufacturer to implement a new product development process and stage-gate process, enabling them to streamline their innovation process.
What interesting projects are you working on at the moment?
My role at CDP is to help ensure the medical devices we design pass smoothly through the regulatory process. The company gained its ISO accreditation in 2014 and I’ve been brought on board to proactively engage with the various teams about quality - ensuring that we conduct all of our projects in the best way we can, and to see that the design controls required by medical clients are adhered to whilst providing the flexibility our consumer clients require. Not all of our clients know that we already provide support in generating quality documentation, and we can also support them during verification and manufacturing transfer with related quality and process controls.
What are the hot trends in this area at the moment?
A major topic for a while has been the upcoming revision of ISO9001: 2015 and ISO13485: 2016 – which will involve a significant rewrite of these long established standards. The main change is that the emphasis will firmly be on risk management. Risk assessments will have to be conducted to determine what activities need to be prioritised and this will then facilitate the tailoring of quality activities to an individual company and client’s needs.
Additionally, the competency of individuals will have to be proven through evidence of successfully delivered projects and solid experience, rather than just showing someone has undertaken training, as previously interpreted from the standard. This is of course more of a subjective quality to provide evidence for and it will be interesting to see how this is measured going forward.
What hobbies do you have outside work?
When I can fit it in – aside from juggling work and family life, as I have a 2 year old son – I am a motor sports enthusiast. I grew up on the side of race tracks with my parents racing nearly every weekend! After learning about building and racing cars with my father from an early age, I bought my first car when I was 16: an MG Midget. We restored it from a sorry state and modified it, and I then took it out racing myself.
And as a total change to being a petrol head, I’m also an assistant beekeeper! My husband and I currently have 2 hives – which house approximately 40,000 bees per colony – so last year we literally had more honey than we could give away! It’s fascinating tasting the difference between the first flow, which is set honey around May time, when the bees have collected pollen from oil seed rape – to the second flow later in the summer, which is much more floral from the pollen of summer flowers around our house. I’m thinking of ways of making use of the beeswax this year too…
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12 September 2019
Chosen as a subject matter expert, Helen Simons discusses her input into the US fundamentals book published by RAPS looking at the requirements of the FDA.
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