Company background and the medical field

Cystotech is a Danish MedTech company working in the field of Urology to transform the future of Bladder Cancer treatment.

In Cystotech, we are developing applications for use during cystoscopy procedures of the urinary bladder and are focused on aiding and improving the diagnostic performance to drive less invasive approaches to treatment for the benefit of patients and healthcare costs.

About the job

Would you like to join a team of dedicated people committed to making a difference for bladder cancer patients and assisting us in continuous regulatory compliance for an innovative medical device, improving patient care and outcomes from a global perspective? Then join us in Advancing AI-Driven Solutions for Bladder Cancer.

We are a passionate team dedicated to making a meaningful difference in the lives of bladder cancer patients. Our mission is to develop innovative medical devices powered by artificial intelligence, with a strong focus on quality, regulatory compliance, and operational excellence.

To support our continued growth, we are expanding our team with a full-time Technical QA Assistant (37 hours/week). If you are a skilled and committed professional ready to contribute to the development of cutting-edge AI-based medical technology, we would love to hear from you.

As part of our team, you will find a dynamic, collaborative, and purpose-driven work environment, located centrally in Aarhus, Denmark.

Now, we seek a skilled and committed Technical QA Assistant to expand our team.

As we are developing software-based medical devices, ensuring compliance with the regulatory frameworks is a high priority for the company.

As a Technical QA Assistant at Cystotech, you will be part of a highly dedicated team still evolving and growing.

You will be working in a dynamic and positive work environment with a dedicated team.

A full-time position (e.g., 37 hours per week), working primarily at our office in Aarhus, Denmark.

Desired start date: as soon as possible.

Educational background & experience

The below-listed experience is not a requirement, yet a high preference:

• Experience with Quality Management for SaMD

• Bachelor’s or Master’s level in a scientific discipline

• Experience working with regulatory frameworks

• Experience with ISO 13485, ISO 14971, and preferably also IEC 62304, IEC 62366

• Detailed oriented, yet consciously pragmatic and solution-oriented

• Willingness to learn

In the role of Technical QA Assistant, you will gain in-depth insight into our Quality Management System, and your primary responsibility will be to collaborate with the R&D Team in continuous product development while ensuring compliance with the internal procedures and applicable regulatory framework focused mainly on the EU and US legislation. You will interact closely with the Management Team to provide and prioritize the technical workflow of future features and the expansion of the company’s product portfolio.

Responsibilities

Product development

• Continuous surveillance of the development plan, including phases planned for the product portfolio

Machine Learning

• Ensure quality assurance & compliance throughout the Machine Learning Development

  • Continuous and regular compliance review of the ML-related development

Software Development

• Continuous and regular compliance review of the Software-related development

• Conduct regular design reviews to ensure compliance checks against the defined requirements

• Plan regular code reviews to check the compliance of the code/ implementation

• Plan and conduct regular reviews of SOUPs to support compliance within the R&D development

• Assist the software team with the implementation of processes and plans

Requirements

• Management of the product requirement process

• Ensuring safety and security risk considerations and analysis

Regular Design Reviews

• Identify and formulate User needs, Use Requirements, & System requirements

• Maintenance QA could be responsible for controlling if the maintenance tasks, processes, plans, and deliverables are done correctly and in time, while the person responsible for the maintenance as a whole is the same

Maintenance

• Overseeing and controlling the planned maintenance tasks, processes, plans, and deliverables according to the development phases of the individual products