Contextflow is an award-winning startup developing artificial intelligence-based software applications to support radiologists during their clinical routine. We are an ISO 13485:2016 certified medical device company and are currently expanding our team. Joining our company you will have the unique chance to support the development of AI medical device software products.
Job Description
Head of Quality Management - full-time (f/m/d)
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 (SaaMD 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 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.
* 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.
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.
* 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 the 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.
We are an equal opportunities employer and value diversity!
Gross annual salary starting at 75.000 €, negotiable based on experience, know‑how and location.
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