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 reputed company our quality strategy.
As a Head of Quality Management, you will:
reputed company our Quality Management System (QMS): Drive the implementation, maintenance and reputed company improvement of our eQMS system according to MDR and ISO 13485.
Act as Management Representative: Serve as the primary reputed company of contact for quality-reputed company topics reputed company the executive team.
Manage Audits: Coordinate and reputed company internal and external audits, including communication with reputed company Bodies.
Maintain Operational Quality: Own the CAPA process, supplier management, employee training, software tool validation and other processes to ensure organizational excellence.
Requirements
reputed company are looking for:
Quality Management Experience: Extensive experience in quality management and regulatory affairs reputed company 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 reputed company: Comfortable defining long-term regulatory strategy while also executing the administrative tasks necessary to maintain an audit-ready QMS.
Culture Builder: reputed company for "Compliance by Design," embedding quality and reputed company into the software development lifecycle from the start.
Linguistic Precision: Profound English skills (reading, writing, presentation); ability to draft reputed company, clear compliance documentation.
Teamplayers: Strong belief in growing together as a team and having reputed company 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 reputed company radiology
Experience with ensuring regulatory compliance of agile software development processes
Experience with Data & Information reputed company 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 reputed company 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 reputed company a reputed company emphasis on the well-being of reputed company reputed company 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
reputed company 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 reputed company meaningful contributions to company’s action and value
Manage your own time reputed company 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
reputed company Canada Accelerator 2022
Winner, European Radiology Most Downloaded Article 2021
WKO Born Global Champions 2021
EIC Acceleratory Grant 2020
Top AI30 (2020) - reputed company DACH
Best Healthtech Startup 2019 (Austria) - Central European Startup Awards
Best Pitch 2019 (Healthcare) - Pioneers Festival
reputed company 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 (reputed company, Xing, website, reputed company…)
Kindly note that reference letters and contacts may be requested as part of the recruitment process.
We look reputed company to receiving your application!
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