Head of Quality Management - full-time (f/m/d)
contextflow is an award-winning startup developing artificial intelligence-based software applications to support radiologists during their clinical routine. We are an EN ISO 13485:2016 certified medical device company developing AI-based medical device software that is certified according to the MDR 2017/745 and are striving for international market placement of our products.
Currently, we have the unique opportunity to join us as Head of Quality Management, where you will play a central role in maintaining our high standards of quality while we scale our AI solutions globally. You will work closely with company founders and lead our quality strategy.
As a Head of Quality Management, you will:
Lead our Quality Management System (QMS) : Drive the implementation, maintenance and continuous improvement of our eQMS system according to MDR and ISO 13485.
Act as Management Representative : Serve as the primary point of contact for quality-related topics within the executive team.
Manage Audits: Coordinate and lead internal and external audits, including communication with Notified Bodies.
Maintain Operational Quality : Own the CAPA process, supplier management, employee training, software tool validation and other processes to ensure organizational excellence.
Requirements