Quality Director
Vor 2 Tagen
Wyss Zurich_
**Quality Director**
**70-100 % **:The Wyss Zurich Translational Center (Wyss Zurich) is a joint accelerator of the ETH Zurich and the University of Zurich, which was made possible by a generous donation from the Swiss entrepreneur and philanthropist Dr. hc. mult. Hansjörg Wyss. The mission of Wyss Zurich is to drive the clinical translation and technology transfer of outstanding scientific discoveries into new therapies for patients and breakthrough innovations in the emerging fields of Regenerative Medicine and Robotics, and to promote hybrid technologies in these fields. Wyss Zurich brings together some of the world's leading experts to form multidisciplinary teams, pooling their knowledge and expertise.
The project MUVON is developing a low-risk, mínimally invasive treatment that uses the patient's own muscle precursor cells (MPC) to regenerate the damaged sphincter muscle, thus potentially providing a cure for stress urinary incontinence, as the first target indication. Having reached the end of Phase I clinical trial, the MUVON project has been supported by Wyss Zurich and will now proceed with the clinical and commercial development of their therapy, evaluating the efficacy of the approach during a Phase II clinical trial and undertaking all the required activities for regulatory approval. We are a young, dynamic, energetic team with outstanding dedication to bringing a significant change in patient's lives and have founded in 2020 the UZH Spin-off MUVON Therapeutics which is linked to this project.
**Your responsibilities**:
- Responsible for the creation and maintenance of the technical documentation as part of the eQMS
- Responsible for the product development(s) in the project and for compliance with the Regulatory and/or legal requirements for product development
- Plans and ensures execution of all development activities, particularly design verification and validation including usability validation.
- Fulfilling the reporting obligations on serious incidents
- Creating, reviewing, and releasing of the development file (DHF)
- Authorises the drawing up of declarations of conformity
- Coordinates and oversees risk management activities
- Member of the Design Review Team
- Participates in continuous improvement (report deviations and report improvement suggestions)
- Coordinates development activities in consultation with the Project Manager and Project Manufacturing Engineer, if applicable
- Performing post-market surveillance; if applicable
- Support the quality manager in QMS implementation
**Your profile**:
- Successfully finished studies in natural sciences (Bachelor/Master), preferably in the area of biotechnology, engineering, pharmaceutical technology, biology, or a comparable education.
- 5-15 years' work experience with medical device quality/production
- In-depth ISO 13485 and MDD/MDR knowledge
- Understanding of quality standards
- Process data understanding is a plus
- Experience in regenerative medicine is a plus
- Project management nice to have (e.g., PMP certified)
- Experience in establishing a QMS is a plus
- Very good language skills in English and German
- Independent and proactive working attitude
- Quality thinking, analytical and structured work, problem solving ability, communication skills
- Flexible team player with entrepreneurial spirit
**What we offer**: We are a young, energetic team with outstanding dedication to bringing a significant change in patient's lives. Therefore, we have founded the UZH Spin-off MUVON Therapeutics in 2020, which is linked to this position and the phase II study. Our goal is to further strengthen the medical device quality team for the phase II productions at the Wyss Zurich, as well as drive the development of our revolutionary therapy and provide an opportunity to extend employment through MUVON Therapeutics and participation in Startup success.
**Place of work**: Weinbergstrasse, Zürich, Switzerland
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