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Quality engineer

Zürich
ETH Zürich
Ingenieur Qualitätssicherung
Inserat online seit: Veröffentlicht vor 18 Std.
Beschreibung

At Versive, we're transforming manual wheelchair use with our patented steering-by-leaning system, making propulsion up to twice as efficient, enabling easy one-handed propulsion, and delivering a smooth, intuitive movement experience. We started as a Wyss Zurich Project in 2025 and are now growing our team to bring this groundbreaking technology to market and ultimately improve mobility and activity of users. If you're passionate about impactful design, inclusive technology, and meaningful innovation - we'd love to hear from you! Project background The Wyss Zurich Translational Center (Wyss Zurich) is a unique accelerator, embedded within ETH Zurich and the University of Zurich, that is dedicated to the emerging fields of regenerative medicine, robotics, and medical devices/bionics technologies. Wyss Zurich was established by a generous donation from the Swiss entrepreneur and philanthropist Dr. hc. mult. Hansjörg Wyss to foster translational projects from ETH Zurich and/or the University of Zurich. Wyss Zurich supports projects focusing on developing treatment protocols and clinical therapies, as well as novel technologies and intelligent systems in the emerging fields of regenerative medicine, robotics, and medical devices/bionics technologies. Job description As our Quality Engineer, you'll work closely with the R&D team to lead our testing and quality assurance efforts. You'll drive the implementation of our Quality Management System (QMS) and ensure our Class I medical devices meet the highest standards of quality, safety, and regulatory compliance. You'll also help shape our agile startup culture and champion a shared commitment to delivering impactful, user-centered solutions. Responsibilities:
* Implement and maintain a QMS compliant with ISO 13485, in collaboration with Wyss Zurich QM experts
* Drive requirements engineering in close alignment with R&D
* Lead risk management activities, including risk assessments and mitigation planning
* Oversee and perform in-house durability testing of our wheelchairs
* Plan and coordinate usability and clinical evaluations
* Prepare and maintain technical documentation for CE marking
* Liaise with external regulatory partners to ensure alignment during development
Profile
* Bachelor's or Master's degree in engineering, life sciences, health sciences, or a related field
* 3-5 years of hands-on experience in medical device development
* Solid knowledge of ISO 13485 and related regulatory frameworks
* Experience with CE marking or FDA clearance for Class I medical devices (preferred)
* Training or experience in design, manufacturing, or quality control is a plus
* Strong communication, problem-solving, and team collaboration skills
* Experience in regulatory affairs is an advantage
* Fluent in English; additional languages are a plus
* Self-motivated, adaptable, and excited about working in a startup environment
* Willing to work on-site in Zurich
We offer
* A motivated, mission-driven team dedicated to improving lives
* A culture of continuous learning, experimentation, and innovation
* The chance to shape a growing company from the ground up
* An inclusive, supportive work environment with strong team spirit
* Benefits aligned with the ETH Zurich employee benefits program

> Working, teaching and research at ETH Zurich We value diversity
In line with our values, ETH Zurich encourages an inclusive culture. We promote equality of opportunity, value diversity and nurture a working and learning environment in which the rights and dignity of all our staff and students are respected. Visit our Equal Opportunities and Diversity website to find out how we ensure a fair and open environment that allows everyone to grow and flourish.

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