Koite Health is looking for QA/RA leader to develop company operations and lead the fulfillment of global medical device regulations in American, European and Asian markets. The quality chief works with the company CEO, R&D and marketing to supervise the ISO13485 quality system operations, management of product technical file and new product development. The growth company quality chief role is closely tied to company strategy in identifying and meeting new market regulatory requirements and is an excellent opportunity to be part of a unique Finnish growth story. 

Koite Health is a fast-growing medical technology company innovating light-activated antibacterial solutions. Our solutions treat and prevent bacteria-caused infections and partly solve the global antibiotic resistance problem. The Koite team consists of experienced engineers, medical doctors, and business experts with decades of experience in medical devices and life science. The first product Lumoral was launched to prevent and treat oral diseases with a focus on the treatment of periodontal disease.

We are looking for a team player who fills the MDR quality chief requirements, has prior experience in medical device regulation and ISO13485, and has been in a key role in achieving sales permits to one or more medical devices in FDA or CE (class IIa or higher).