Quality Engineer (m/f/d)

Your missionAs a key member of our R&D department, you will serve as the pivotal link between research and quality, ensuring our cutting-edge development work aligns seamlessly with regulatory standards. This role holds significant influence, shaping the QMS within our R&D landscape. You’ll drive quality from concept through to execution, leaving your fingerprint on technologies that transform lives.Your responsibilities:Act as the central interface between the R&D department and the company-wide QA division, ensuring continuous collaboration and alignment on quality-related topicsEstablish, maintain, and continuously improve the QMS framework within the R&D environment, in alignment with ISO 13485 / Section 7.3 (Design and Development)Ensure ongoing compliance of Clinical Polarizer (Lean Pharma Plan/Device) development with QMS standards by actively monitoring and reviewing development activities.Administer the QMS tool and manage our internal standards databaseAnalyze product defects, complaints, and non-conformities, initiating and tracking corrective and preventive actions (CAPA) as necessaryPlan, organize and deliver internal training sessions on quality-related topics to promote awareness and compliance across the teamPlan and execute internal and external audits, assist with supplier qualification and monitoring, and follow up on audit findings to drive continuous improvement.Lead the risk management process for the development of the Polarizer, from initial hazard identification through risk analysis, evaluation, and mitigation. Develop and maintain all related risk management documentationSupport ongoing development activities of the Preclinical Polarizer by providing expert input on QA-related aspects as needed Your profileDegree in engineering, medical technology, computer science, natural sciences, or a comparable field, with 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, with deep familiarity in QMS frameworks relevant to medical or pharma industries (ISO 13485 and/or GMP), and confident use of related software toolsProven expertise in risk management (e.g., ISO 14971, ISO 12100) and 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 plusKnowledge of the approval process for machines and systems for the US market is an absolute plusA well structured, hands-on approach with strong analytical skills and results-orientated way of workingFluent in English, with strong written and verbal communication skillsComfortable with working in an international and crossfunctional team in a highly dynamic and rapidly developing environment, with a willingness to play a key role in shaping the company in your area of responsibility Why us?Competitive compensation, including base salary and virtual sharesOnsite work (Ulm) in a modern office/lab environment with home-office opportunities (no relocation necessary)Attractive relocation package (if necessary)Annual health budget (Allianz bKV)30 vacation daysFlexible working hoursKey role in a highly advanced and fast-growing startup companyAmple opportunity for personal initiatives, openness to new ideas, and room for considerable personal impactImpactful product promoting better understanding and treatment of diseaseInternational and dynamic team, comprising over 20 different nationalitiesEGYM Wellpass membershipPermanent employment contract, providing stability and long-term career growth opportunitiesEnjoyable work atmosphere with an open-door and open communication mentality By submitting your application, you acknowledge and agree to our data protection and privacy policy.