Quality Engineer (m/f/d)

Your mission

As 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.

• Act as the central interface between the R&D department and the company-wide QA division, ensuring continuous collaboration and alignment on quality-related topics
• Establish, 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 database
• Analyze product defects, complaints, and non-conformities, initiating and tracking corrective and preventive actions (CAPA) as necessary
• Plan, organize and deliver internal training sessions on quality-related topics to promote awareness and compliance across the team
• Plan 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 documentation
• Support ongoing development activities of the Preclinical Polarizer by providing expert input on QA-related aspects as needed

Your profile

• Degree 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 tools
• Proven 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 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, 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 shares
• Onsite 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 days
• Flexible working hours
• Key role in a highly advanced and fast-growing startup company
• Ample opportunity for personal initiatives, openness to new ideas, and room for considerable personal impact
• Impactful product promoting better understanding and treatment of disease
• International and dynamic team, comprising over 20 different nationalities
• EGYM Wellpass membership
• Permanent employment contract, providing stability and long-term career growth opportunities
• Enjoyable work atmosphere with an open-door and open communication mentality

contact information

Any questions? Please contact:
Sandra Schärli
Senior Talent Acquisition Manager
mail:
Please note that, for data privacy reasons, we\'ll not review applications or CVs sent via email. Unsolicited applications can be submitted here .

#J-18808-Ljbffr