Are you passionate about how technology can make a real impact on cancer? Join us at kaiko.ai in building the state-of-the-art Data & AI platform, enabling large-scale training of multi-modal foundation models, and transforming the clinical workflow to deliver better patient outcomes.

Our culture

At kaiko, we have an open, creative and autonomous work atmosphere which offers continuous learning and direct impact in return for accountability and team spirit.

We offer flexibility - for instance, through remote working – alongside an expectation for managing and delivering your own goals; our team’s ownership, passion and shared commitment to improving health outcomes through data is something that sets us apart.

At the intersection of healthcare and data we recognize the implications on wellbeing and trust and approach our work with the utmost sensitivity. Data privacy, compliance and security are core to everything we do. Our open, creative environment gives talented people room to explore new ideas, and we reward this with an attractive package and opportunities for further personal development.

As our Senior Quality Assurance 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 development, 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

Required Qualifications and Skills

• 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.

Your interview process at Kaiko:

1. Screening interview: A 30 mins interview to get to know you and your motivation to join Kaiko
2. Business case / technical assessment: a 2-hour, asynchronous test task to evaluate your skills
3. Hiring manager interview: A deep dive with your potential manager and team members to explore your technical expertise and discuss past experiences in detail.
4. CEO interview: A 45-minute conversation with our CEO to gain insights into our company strategy and growth plans, as well as align on vision and values.