QM Specialist (CAPA and Change Management) (d/f/m)

We believe that AI has the potential to revolutionize how cancer and other complex diseases are diagnosed and treated. We also believe that AI is a tool, not an identity – without access to high quality data and a scientifically rigorous, transparent approach to model development, AI is just a buzzword. That’s where we come in.

Aignostics is a spin-off from one of Europe's largest and most prestigious university hospitals (Charité), with employees in Berlin and New York. We have received over $50M in funding from leading investors and are a growing team of over 100 interdisciplinary professionals. We work with academic partners as well as leading global life sciences companies.

As a QM Specialist (CAPA and Change Management) you'll own the development and execution of our corrective and preventive action (CAPA) systems and change management processes—ensuring quality issues are systematically resolved, product changes are implemented swiftly yet compliantly, and that our organization continuously learns and improves. Your work directly impacts our ability to deliver transformative healthcare solutions to patients worldwide. In this strategic position, you'll be instrumental in maintaining our ISO 13485 certification and ensuring that our cutting-edge AI products meet the highest quality and regulatory standards.

This is a unique opportunity to join a fun, diverse, and growing team of 100+ data scientists, software developers, biologists, and pathologists to shape the next generation of cancer treatments. You will be part of a driven community that works in an agile, supportive and interdisciplinary research environment where your results make a difference to patients. In our established startup you have the opportunity to grow personally and technically, take responsibility and benefit from a dynamic work environment.

At Aignostics, we believe that fighting cancer is a job for people of all identities, backgrounds, and cultures. We value and celebrate diversity and inclusion and are committed to offering equal employment and promotion opportunities for all applicants and employees. Applicants will be considered regardless of their age, disability, ethnicity, race, gender identity or expression, sexual orientation, religion, etc. We thrive through collaboration and believe the more inclusive we are, the better our work will be.

Where your expertise is needed

Build Robust Quality Systems:

• Establish and maintain CAPA management systems in full compliance with ISO 13485

• Design and oversee change management processes aligned with ISO 13485 and IEC 62304

• Maintain comprehensive QM documentation including SOPs, work instructions, and quality records

• Translate regulatory requirements (IVDR, ISO 13485, FDA QSR) into actionable QM system elements

• Analyze quality and change data to identify trends, systemic issues, and improvement opportunities

Enable Cross-Functional Excellence:

• Partner with software engineers, data scientists, and product teams on root cause analysis and corrective measures

• Coordinate and support internal and external audits (notified body, regulatory authorities)

• Facilitate CAPA and change review meetings where diverse perspectives are heard and the best ideas win

• Build collaborative relationships across all departments to embed quality thinking everywhere

Foster a Learning Culture:

• Develop and deliver training programs on CAPA management, change control, and quality processes

• Share lessons learned from CAPAs and audits to drive organizational learning

• Create a psychologically safe environment where quality concerns can be raised openly

• Mentor team members and stakeholders in quality management principles

What we are looking for

• Proven expertise in quality management systems, CAPA methodologies, and change control processes

• Strong proficiency with root cause analysis tools (5 Whys, Fishbone diagrams, Fault Tree Analysis)

• Solid understanding of ISO 13485, ISO 14971, IEC 62304, IVDR, and 21 CFR Part 820

• Experience planning, conducting, and supporting internal and external audits

• Excellent written and verbal communication skills in English

• Ability to influence and collaborate effectively with diverse stakeholders at all levels

Our offer

• Join a purpose-driven startup: We are working collectively to fight cancer and improve patient outcomes. Come help us make a difference!

• Fun, cutting-edge AI research and development, with involvement of Charité, TU Berlin and our other partners

• Work with a welcoming, diverse, and highly international team of colleagues

• Ability to take responsibility and grow your role within the startup

• Competitive remuneration package in addition to perks and benefits

• Expand your skills by benefitting from our Learning & Development yearly budget of 1,000€ (plus 2 L&D days), language classes and internal development programs

• Mentoring program, where you'll learn from and mentor great experts

• Flexible working hours and teleworking policy

• Enjoy your well-deserved time off with 30 paid vacation days per year

• We are family & pet friendly and support flexible parental leave options

• Pick a subsidized membership of your choice among public transport, sports, and well-being

• Enjoy our social gatherings, lunches, and off-site events for a fun and inclusive work environment

• Optional company pension scheme

Join us to make a difference!