Director in Quality and Regulatory Affairs Tiina Kotipalo

Tiina Kotipalo, Director in Quality and Regulatory Affairs

Tiina Kotipalo was appointed Innokas Medical’s Quality and Regulatory Affairs Director in 2013. Before that she worked in various roles at Innokas, including Software Developer, Project Manager and Quality Manager. Today when working as a QA/RA Director, Kotipalo is responsible for overall quality and regulatory issues affairs at all three of Innokas Medical’s plants.

At Innokas Medical, quality is built into our services and products.

I have Bachelor’s Degree in Business Information Technology from Oulu University of Applied Sciences. I graduated in 2003. Later I’ve also received additional training in quality management and regulatory affairs by participating in several courses arranged by different Finnish and foreign training companies. Additionally I have always been eager to learn new by self-learning from different sources. At Innokas Medical we have been lucky to have very good customers that have increased our level of knowledge in medical technology area during over 20 years.

 

I came to work at Innokas in 2003 at first to work as a Software Developer. Quite soon I was promoted as a Project Manager to take responsibility of different kind of medical device projects we were implementing to our customers. In 2009 I started to work at Innokas’ quality department first as a Quality Manager, then as a QA/RA Manager and today my role is QA/RA Director. In my current role, my primary task is to take the overall responsibility of quality and regulatory affairs at Innokas. In practice, I’m leading Innokas’ Quality Processes, and I’m also taking care that our medical device design and manufacturing processes follows all the needed regulatory requirements. I’m also lucky to be able to participate different customer projects as a QA/RA consultant where I’m helping our customers to meet different regulatory requirements such as EU Medical Device Directive and FDA QSR requirements.

 

I’d say that constantly changing jungle of all different rules and regulations is one of the biggest challenges in my work. Compared with other industries, the medical device industry has significant amount of regulatory requirements that describes how we exactly have to operate. For example, Innokas Medical has been granted with ISO 9001:2008 and ISO 13485:2003 quality system certification; and the latter standard specifies quality system requirements for medical device designers and manufacturers. In addition, the EU’s medical device directive (MDD) describes how we as a manufacturer of medical devices have to operate. The official requirements concerning medical devices are very strict. It is not enough to have a good end product—the production process also has to fulfill certain criteria. Device manufacturers must also be able to prove that they operate according to these requirements, and the documentation needs to be done with high quality and proven traceability also. In other words, we have to be familiar with official regulations and we have to be able to implement them in practice. Everything in the entire production process, from component purchasing to sending finished products to customers, and even “after-sales service” (e.g. customer feedback), must happen according to these regulations. Sometimes it feels it is the jungle of rules and regulations, but I have to admit that as much it is challenging, it is also very inspiring. It is very pleasing to challenge myself to continuous learning and adaptation. I’m proud that I can influence with my work to the safety and effectiveness of medical devices. I feel it motivates me most.

 

I have really enjoyed working at Innokas. The enthusiastic working community, good working atmosphere and diversified job have kept me at Innokas for 12 years already. I especially value that in my role I’m able to continuously learn new things and I have a privilege to work with a very competent team full of experts in medical device area at Innokas and our customers. It is very rewarding to be involved in of all the phases in medical device design and manufacturing processes and to be able to see a product way from designers’ workbench to market.

 

On my free-time every day I go walking with my dog. I also spend my leisure time to do different kind of outdoor activities like canoeing, skiing, mountain biking and trekking. At home I love reading, baking and spend time with ‘Do It Yourself’ -projects.