Act as the central interface between the R&D department and the company-wide QA division
Ensure continuous collaboration and alignment on quality-related topics
Establish, maintain, and continuously improve the QMS framework within the R&D environment
Ensure ongoing compliance of Clinical Polarizer development with QMS standards
Administer the QMS tool and manage our internal standards database
Analyze product defects, complaints, and non-conformities, initiating and tracking corrective actions
Plan, organize and deliver internal training sessions on quality-related topics
Plan and execute internal and external audits
Lead the risk management process for the development of the Polarizer
Develop and maintain all related risk management documentation
Support ongoing development activities of the Preclinical Polarizer by providing expert input on QA-related aspects

Degree in engineering, medical technology, computer science, natural sciences, or a comparable field
Several years of hands-on experience in regulated product development—ideally in pharmacology, medical technology, cosmetics, or laboratory equipment
4+ years of professional experience as a Quality Engineer
Deep familiarity in QMS frameworks relevant to medical or pharma industries (ISO 13485 and/or GMP)
Confident use of related software tools
Proven expertise in risk management (e.g., ISO 14971, ISO 12100)
Practical application of hazard evaluation methods such as FTA, FMEA, Ishikawa, or HAZOP
Experience with CAPA tools (e.g., 8D reports)
Certifications in these areas are a strong plus
Knowledge of the approval process for machines and systems for the US market is an absolute plus
A well structured, hands-on approach with strong analytical skills and results-orientated way of working
Fluent in English, with strong written and verbal communication skills
Comfortable with working in an international and crossfunctional team in a highly dynamic and rapidly developing environment

Attractive compensation package, including a competitive base salary and stock options
Key role in a highly advanced and fast-growing startup company
Impactful product promoting better understanding and treatment of cancer
International team, from over 30 different nationalities
Positive work environment with open communication and a collaborative mindset
Onsite work at state-of-the-art facilities with home-office opportunities
Indefinite employment contract
30 vacation days
Flexible working hours
Annual health budget (Allianz bKV)
EGYM Wellpass
Relocation support

Quality Engineer

Key skills