Aiosyn is on a mission to accelerate the adoption of Artificial Intelligence in pathology with the potential to improve the chances of patients worldwide. Aiosyn develops precision pathology algorithms that boost the efficiency and quality of diagnostics in breast cancer and chronic kidney disease using AI.
We are a growing team of AI enthusiasts and engineers transforming state-of-the-art algorithms into certified medical devices that can be used anywhere, anytime. Our AI solutions will benefit millions of patients in pathology diagnostics worldwide.
We are looking for a Quality Assurance manager to strengthen our RA/QA team. You will develop and lead our QMS and support product development to make our AI available anywhere, anytime.
What your responsibilities would look like:
- Maintain our quality management system (QMS) in compliance with relevant standards and regulations.
- Coach and guide the engineering and product teams on QA and ensure Aiosyn’s software and product development processes comply with the latest standards.
- Work in close collaboration with our regulatory team to ensure compliance with the latest medical device regulations, standards, and guidelines.
- Lead and be a team member on the identification, assessment, and mitigation of risks associated with our medical devices, as well as maintaining the Risk Management File.
- Plan and conduct internal audits in collaboration with the regulatory team. Participate in the Notified Body external audits to ensure compliance.
- Manage the CAPA process, including identifying non-conformities, analyzing root causes, and implementing corrective and preventive actions.
- Lead essential aspects of our QMS, including supplier management, tool validation, KPIs / effectiveness assessment.
- Drive a culture of continuous improvement, proactively identifying opportunities to enhance processes and documentation.
What your background looks like:
- A bachelor’s degree (HBO or WO) in a field relevant to Aiosyn or the profile of QA manager (engineering, life-sciences, pharmacy, law, etc.).
- Two years of experience working with a quality or information management system and applying relevant standards.
- Experience with managing an eQMS and being responsible for QA.
- Fluent in English, both speaking and writing (technical documentation).
- A team player that can work independently.
A plus would be:
- Affinity and experience with Software as a Medical Device (SaMD), for example, demonstrable experience in applying standards such as IEC 62304.
- Demonstrable experience in relevant standards to Aiosyn, for example ISO13485, European Medical Device Regulations (MDR or IVDR), medical devices under the FDA, ISO27001, FDA 21 CFR Part 820, ISO 1497.
What we offer:
- An opportunity for career growth in an international, exciting, fast-paced medtech startup.
- A good purpose: our products will help doctors assess complex diseases like cancer to benefit patients and society.
- A very flat work hierarchy where your opinion will always be listened to and will impact what we do.
- A welcoming atmosphere with a positive vibe, where work-life balance is a priority.
- An opportunity to lead others, learn by doing, receive training, and be the best version of yourself.
- Flexible working hours, the possibility of working from home, and a cool office on the university campus surrounded by green areas (even a botanical garden) in Nijmegen.
- A salary of 4000-6000 EUR per month (gross salary excluding holiday allowance, depending on experience and background, 40h/week).
- Public transport (based on 2nd class).
- 25 holidays per year (plus additional public holidays) based on a full-time contract.
- This position is for 32-40 hours.
- This is a hybrid position. You can either work full-time from our office or combine working from our office with part-time work from home.
- You must live in the Netherlands and have a permit to work in the Netherlands (e.g., EU citizenship). Please note that, as of this time, Aiosyn cannot act as a recognized sponsor.
- The application procedure will consist of an online interview, assessment, and an on-site visit. Additional interviews might be needed based on a case-by-case basis.
Aiosyn B.V. is an equal opportunity employer dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications. We do not discriminate on race, gender, religion, health, personal beliefs, age, family, or parental status, or any other status.