Quality Engineer (m/f/d)

NVision Imaging Technologies; Ulm; Hybrid; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

A medical technology startup in Ulm is seeking an experienced Quality Engineer to oversee the Quality Management System (QMS) within the R&D department. The role involves ensuring compliance with regulatory standards and leading risk management processes. Ideal candidates will have over 4 years of relevant experience in regulated product development and strong analytical skills. Competitive compensation and flexible working hours are offered.

Leistungen

Competitive compensation including virtual shares

30 vacation days

Flexible working hours

Annual health budget

EGYM Wellpass membership

Qualifikationen

• 4+ years of experience as a Quality Engineer in regulated product development.
• Experience in QMS frameworks relevant to medical or pharmaceutical industries.
• Proven expertise in risk management and hazard evaluation methods.

Aufgaben

• Ensure compliance with QMS standards in product development.
• Lead risk management processes for product development.
• Conduct internal audits and provide training on quality topics.

Kenntnisse

Quality Management System (QMS) expertise

Risk management knowledge

Analytical skills

Fluent in English

Ausbildung

Degree in engineering, medical technology, computer science, or related field

Tools

CAPA tools

Software tools relevant to QMS

Jobbeschreibung

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:[e-mail]
Please note that, for data privacy reasons, we\'ll not review applications or CVs sent via email. Unsolicited applications can be submittedhere.