Head of Quality Management (f/m/d)
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 What we are looking for: Quality Management Experience : Extensive experience in quality management and regulatory affairs within the medical device industry (Software as a Medical Device in Radiology AI preferred). Regulatory Expertise : Expert knowledge of ISO 13485, MDR (EU) 2017/745, IEC 62304, ISO 14971, ISO 27001, FDA, and MDSAP Strategic Thinking : Ability to define and track OKRs (Objectives and Key Results) that align with the company's quality policy and mission. Hands-on Mindset: Comfortable defining long-term regulatory strategy while also executing the administrative tasks necessary to maintain an audit-ready QMS. Culture Builder: Advocate for "Compliance by Design," embedding quality and security into the software development lifecycle from the start. Linguistic Precision : Profound English skills (reading, writing, presentation); ability to draft complex, clear compliance documentation. Teamplayers: Strong belief in growing together as a team and having empathy for each other Structured work style and high level of self-motivation Work permit in EU Open to travel on a quarterly/monthly basis Bonus Skills: Experience with regulating / clearing AI-based image analysis solutions within radiology Experience with ensuring regulatory compliance of agile software development processes Experience with Data & Information Security topics Experience with JIRA or similar project management / issue tracking tool German, Dutch or any Scandinavian language a plus Benefits What you can expect: You will be part of an interdisciplinary team, characterized by close collaboration and sharing of knowledge across boundaries of individual fields. We are focused on developing cutting-edge deep learning techniques that serve the rapidly-advancing needs of precision medicine and clinical practice. We place a huge emphasis on the well-being of all our team members. We take care and support each other so that we can grow together. We work hard but also enjoy spending time together. Moreover, you will: Become part of a team of AI medical image processing experts Thrive in a young, dynamic learning environment where you can grow Work on the exciting topic of certification of AI software technology Work directly with the founders and make meaningful contributions to company’s action and value Manage your own time via flexible working hours, remote work possible Founded in 2016, we are one of the leading AI medical imaging startups, having grown to 35 people. To date, we have raised over €18 million from VCs and EU grants and work together with renown customers across Europe. Join an award-winning team: EIC Accelerator Equity Program 2023 GE HealthCare Canada Accelerator 2022 Winner, European Radiology Most Downloaded Article 2021 WKO Born Global Champions 2021 EIC Acceleratory Grant 2020 Top AI30 (2020) - Forbes DACH Best Healthtech Startup 2019 (Austria) - Central European Startup Awards Best Pitch 2019 (Healthcare) - Pioneers Festival Philips HealthWorks 2018 - Chosen as one of 19 participants out of 700+ applications Digital Innovation Award 2017 - Austrian Federal Ministry of Education, Science and Research Most Promising Startup 2016 - BCS Search Industry Science & Business Award 2016 - Rudolf Sallinger Fonds We are an equal opportunities employer and value diversity! Salary negotiable based on experience and know-how How to apply: Interested? Send us your CV and your motivational letter with max 1500 characters (~ half a page), letting us know why you would like to join contextflow and how you can best contribute. You may provide links or attachments with information about yourself (LinkedIN, Xing, website, github…) Kindly note that reference letters and contacts may be requested as part of the recruitment process. We look forward to receiving your application!