Senior QRA Officer
About kaiko
In cancer care, treatment decisions can take many days—but patients don’t have that time. One of the reasons for delays? Cancer patients' data is scattered across many places: doctor’s notes, medical imagery, genomics data. At kaiko, we are developing AI foundational models to bring this data together and integrate it into clinical workflows, enabling doctors to make faster, more effective treatments decisions.
We also collaborate closely with the leading Dutch cancer research institute (NKI) on multiple AI research projects and a joint clinical validation initiative. In 2025, we plan on expanding our partnerships to even more hospitals.
We raised significant long-term funding and have offices in Zurich and Amsterdam. Over the past year, our team has nearly doubled in size, now comprising 70+ people from 25 countries. Our multidisciplinary team brings expertise in LLM and foundational model development, data science, product management, compliance, growth, and operations.
About the role
As our Senior QRA Officer, you'll play a crucial role in shaping the future of our state-of-the-art medical AI by ensuring our foundational models meets the highest standards of safety and reliability, and will own the implementation of our QMS.
Key Responsibilities
- Lead the creation, implementation, and maintenance of the Quality Management System (QMS) per ISO 13485
- Ensure that the QMS supports the regulatory compliance and product certification under MDR, IVDR and AI Act
- Lead key QA processes such as management review, internal and external audits, document and record control, non-conformity and CAPA, vigilance and recall
- Support the implementation of key R&D processes, such as software lifecycle process, AI system lifecycle process, risk management process, clinical evaluation, change control
- Drive and support the implementation of key RA processes, such as PMS, PMPF/PMCF, regulatory intelligence, EUDAMED
- Drive initiatives to enhance efficiency, scalability, and robustness of QMS and related quality processes
- Overall, ensure the QMS is fit for purpose, the QMS certification is sustained, and champion the culture of quality within the organization
Why kaiko
At kaiko, we believe the best ideas come from collaboration, ownership and ambition. We’ve built a team of international experts where your work has direct impact. Here’s what we value:
- We act like owners: You’ll have the autonomy to set your own goals, make critical decisions, and see the direct impact of your work.
- We thrive on collaboration: You’ll have to approach disagreement with curiosity, build on common ground and create solutions together.
- We work with ambitious people: You’ll be surrounded by people who set high standards for themselves and others, who see obstacles as opportunities, and who are relentless in their work to create better outcomes for patients.
In addition, we offer:
- An attractive and competitive salary, a good pension plan and 25 vacation days per year.
- Great offsites and team events to strengthen the team and celebrate successes together.
- A EUR 1000 learning and development budget to help you grow.
- Autonomy to do your work the way that works best for you, whether you have a kid or prefer early mornings.
- An annual commuting subsidy.
About you
- Experience:
- Minimum of 4 years of experience in quality assurance roles in the MD or IVD industry, preferably the experience is in a SaMD company.
- Proven experience with QMS development and maintenance under MDR or IVDR.
- Strong understanding of ISO 13485, ISO 14971, and IEC 62304.
- Experience in conducting and managing audits (internal, external, and regulatory).
- Familiarity with software lifecycle processes, agile methodologies, and software validation techniques.
- Preferably, certified Lead Auditor for ISO 13485.
- Preferably, also have experience with FDA quality system requirements
- Skills:
- Excellent problem-solving, organizational, and communication skills.
- Strong ability to work collaboratively in cross-functional teams.
- Detail-oriented mindset with a proactive approach to compliance and quality.
We are excited to gather a broad range of perspectives in our team, as we believe it will help us build better products to support a broader set of people. If you’re excited about us but don’t fit every single qualification, we still encourage you to apply: we’ve had incredible team members join us who didn’t check every box!
- Department
- Quality Assurance & Regulatory Affairs
- Locations
- Amsterdam (NKI-AvL), Amsterdam (Lab42)
- Remote status
- Hybrid Remote
Senior QRA Officer
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