Kinepict Health Ltd. is a Budapest-based SME with a strong innovative focus in X-ray angiography. Our mission is to make x-ray angiography safer and more powerful by universal dose management of up to 90% x-ray dose reduction. To achieve this goal, we have created a unique medical device software called Kinepict Medical Imaging Tool for interventional radiologists and vascular surgeons. This software solution provided safer examinations for more than 10,000 patients in Europe so far. Now we want to grow and spread the technology across the US, the Middle East, and to the whole EU.
TASKS:
· Management, optimization, and development of quality management system and processes for a medical device
· Continuous review and automation of KPIs of quality control processes
· Supervision of production-related quality control activities• Keeping quality management documents up-to-date
· Be part of the MDD – MDR transition
BASE QUALIFICATIONS:
· At least 1-3 years of experience in quality assurance, and management (MDD, medical device market)
· Knowledge of ISO 13485, ISO 14971, ISO 62304, ISO 14155
· Advanced knowledge of the English language (both written and spoken)
· Outstanding communication skills
· Precise and accurate workout, problem-solving ability
· Participation in previous MDR certification is an advantage
BE THE PERSON
· Who is passionate about innovation and works for a good purpose
· Who is open to working in an innovative startup environment and participating in the development of new medical device
WHAT WE OFFER
· Hybrid work opportunity
· Supportive team
CONTACT US
If you are interested, please submit your resume to the following email address:
monika.mantz@kinepict.com