Name: Cecilia Carelse
Job title: Quality Engineer
Tell us about your background: Where did you get your start & what is your role at Artesyn today?
I’ve worked for over fourteen years in medical device manufacturing in ISO 9001, ISO 13485 and cGMP environments at Bausch & Lomb (contact lens plant), Eurofins (contract testing) and Lake Region Medical-Integer (medical guidewires). I have a B.Eng in Mechanical Engineering and a Postgraduate Diploma in Manufacturing Management and Technology including polymer engineering. After graduation, I worked as a Process Engineer for seven years in new production start-ups, equipment and process validations and then engineering support for established production processes, before moving into quality engineering as a Senior QA Engineer responsible for sterilization and cover to the whole plant, production, primary/secondary packaging, at Bausch & Lomb across the weekend shifts. In Lake Region Medical, I was responsible for the quality of coating, core and coil production and supported five quality inspectors.
At Artesyn Ireland, I manage the quality department, support customers’ quality requirements, manage suppliers, and ensure we maintain compliance with ISO 9001 in everything we do. I designed and implemented an ISO 9001 quality management system to help us achieve our registration in April 2019. To achieve this, I created procedures for processes of incoming/outgoing inspections, production planning, assembly, stock control, documentation requirements, training, change control, document control, supplier control, production provision, calibration, nonconformity/CAPA, complaints, validation, context of the organization, quality objectives, risk assessment, management review, and internal audits, with support to design, sales, purchasing, goods in/out, and preventative maintenance to build their procedures, and created over 60 forms, logs, and templates for our qms records.
For our new cleanrooms, we’re aligned with ISO 14644 and ISO 14698 so I’ve completed In-Operation Validations including writing procedures for gowning, cleaning, microbial, particulate, pressure monitoring, and materials transfer. To assist production, I sourced consumables for gowning, cleaning (chemicals and equipment), inspection and packaging.
The quality team in Ireland is currently two people and we’re hoping to increase that as the business grows.
I’m part of the Global Quality Team and enjoy working with my colleagues and finding out what’s happening across the different sites, how we’re handling different and similar challenges and opportunities to ensure we get the best possible quality solutions for our customers.
What do you like about working at Artesyn?
I love learning new things, especially creating new processes, improving them, and planning for the processes we need to fulfill our customers’ current and future expectations. Because Artesyn is developing new products and with new processes coming on-line, there is still the excitement and feel of a start-up in everything we do. There were 10 people working at the Ireland site when I joined and even though we’re up to 23 people, our size gives me the opportunity to work with everyone and with all the processes. And our direct impact through our products on biopharma production is incredible to see and the direction we are heading as a company is absolutely brilliant.
What would you recommend to other women thinking of entering the biotechnology field?
If you have a passion for creating things, engineering is exactly that. It’s creating a toolkit of information on materials, processes, and possibilities. I won’t lie, it can sometimes be tough being the only woman student on your engineering course or the only woman working in a machine shop or the first female engineer in a company but that is what defines and reminds you of how strong you are to be there in the first place.
What is the best piece of advice you ever received?
Pass on everything you learn.