Quality Manager/Quality Engineer 60 - 100 %

As the largest university in Switzerland, the Universität Zürich offers a variety of attractive positions in different subject areas and professional fields. With around 10'000 employees and currently 12 professional profiles for apprentices, the university offers an inspiring working environment in cutting-edge research and education. Apply your talent and your skills with us. Learn more about the UZH as an employer! ### Tasks • Collaboration in the establishment, maintenance, and further development of the ZH3D quality management system, including processes, templates, and documentation structures • Conception, adaptation, and operative implementation (roll-out) of quality management structures in research groups, clinical departments, technology platforms, and development projects • Advising and accompanying project teams regarding quality assurance, documentation, traceability, data integrity, and regulatory expectations • Collaboration in risk analyses, gap assessments, process evaluations, as well as measures for continuous improvement • Support in qualification, validation, and release processes as well as in the processing of deviations, CAPAs, and change controls • Collaboration in the preparation, accompaniment, and follow-up of audits, inspections, and internal reviews • Support in the development and implementation of GxP-relevant training • Contribution to the establishment of a pragmatic, effective, and science-oriented quality culture in the academic development environment Profile • Completed technical, scientific, or comparable degree (HF/FH, Bachelor or Master) or a comparable technical training with further education in quality management • At least three years of experience in quality management, quality engineering, or in quality assurance in the life science, pharma, biotech, MedTech, or clinical research environment • Knowledge of GxP requirements (GLP, GMP, or GCP); experience with ISO 13485, MDR, IVDR, or other regulatory frameworks is an advantage • Experience in the introduction, implementation, or further development of quality management systems as well as in the creation, maintenance, and training of quality-relevant documentation • Ability to support researchers, clinicians, and project teams in a practical manner in the implementation of quality-assured processes and to convey regulatory requirements in an understandable, audience-appropriate, and pragmatic way • Understanding of academic research and development processes as well as interest in translation, innovation, and clinical application • Structured, careful, and solution-oriented way of working, quick comprehension as well as the ability to translate complex requirements into practical processes • High sense of responsibility, initiative, and enjoyment of interdisciplinary cooperation with specialists from research, clinic, quality management, regulatory affairs, and management • Very good German and English skills in speaking and writing We offer you • A versatile and meaningful task at the interface of science, quality management, regulation, and clinical translation • A responsible role with creative freedom in the establishment and professionalization of quality structures in ZH3D • A dynamic university working environment in a growing excellence center with innovative academic projects in the field of medical device development • Collaboration with experts from Quality Assurance, Regulatory Affairs, GxP, research, clinic, and innovation as well as with leading partners in the Zurich university and health ecosystem • The opportunity to help shape a new regulatory consulting and innovation offering with national impact • A dedicated, interdisciplinary team with high motivation for building and design • Flexible working conditions and attractive employment conditions of the Universität Zürich