#Working3D: Six Questions for a Specialist in Quality Control
Today we bring you a new installment of #Working3D, the series of articles in which we give insight into the different jobs that exist in the additive manufacturing industry. Specifically, we will get to know in detail one of the most important aspects in 3D printing: quality control. The main objective of this discipline is to ensure that 3D printed parts achieve the desired result in physical and mechanical terms. This is especially important in the most demanding sectors which are governed by certain certifications that must be met. In this new installment we will understand the day-to-day life of a specialist in quality control for additive manufacturing in the medical sector. We interviewed Anna Cortina, from Avinent, to learn a little more about her professional work and her relationship with 3D technologies.
3DN: Could you introduce yourself?
My name is Anna Cortina and since 2005 I have been working at Avinent Implant System S.L.U. as the Head of the Research and QA&RA (Quality Assurance & Regulatory Affairs) department.
3DN: How did you discover additive manufacturing?
I discovered additive manufacturing when Avinent started offering customized products and the only way to manufacture them was through this technology. We are mainly talking about customized medical devices linked to craniomaxillofacial surgeries, from an anatomical model to an implantable product, including the corresponding surgical guides. Working together with Avinent’s team of engineers and bioengineers has given me the chance to get to know the technology from scratch and to see the enormous possibilities it offers us and what we can offer healthcare professionals so that the patient is the ultimate beneficiary of this type of manufacturing.
3DN: What is your current role at Avinent? What is a typical day like for you?
My day consists of a list of different actions and above all ensuring that we are carrying them out. Among them is compliance with existing regulations regarding the products we manufacture, the processes we use to manufacture those products and the facilities where we manufacture them. I am also in charge of registering new and/or existing products in new markets nationally and internationally. Finally, I am in charge of getting the maximum clinical evidence for our products to comply with a key factor of the new medical device regulation (MDR) and that is to have sufficient clinical data to support all our products both custom and mass-produced. This involves establishing connections with industry professionals interested in participating in projects that lead to scientific publications.
3DN: What are the required qualifications for your position?
The profile of the person who can perform this type of work is very varied, in our department we have different profiles. However what is particular important is experience. Additionally, it is necessary to always be up-to-date with the regulation by training with professionals in the sector.
3DN: What are the biggest challenges you face as a specialist in quality control?
One of the main challenges we face is, for example, a change in regulation, such as the new medical device regulation. Another may be the fact of certifying a completely different product and that will involve training in both the new product and the corresponding regulation. Finally, a challenge I have faced is the registration of products in a new country due to international expansion, as you can encounter very demanding regulations.
3DN: What advice would you give to someone hoping to work in quality control in the 3D printing industry?
It is very important to value working with a team of people from different disciplines. You also have to be open to changes, to new product registrations, to new technologies that will surely imply changes and updates in the certifications of existing or new products. Finally, I would recommend approaching new challenges in a positive way, as well as questioning the why of things and trying to improve them.
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