Senior Quality Manager Research & Development
Develop, maintain, monitor and ensure good application of design and development quality system to ensure compliance to applicable regulations (MDSAP, ISO13485, FDA, MDR, CFDA, KFDA, Health Canada, etc.) and improve business performance
Drive continuous improvement activities to ensure problems are prevented and issues resolved efficiently and economically
Support R&D programs, projects, design transfer and quality issue resolution
Develop the technical and leadership skills of QMS R&D staff
Lead the harmonization of R&D process at our R&D sites
Develop and update SOP's, work instructions and other quality documentation
Monitor changes in quality and regulatory requirements and ensure efficient implementation into respective processes and documentation
Ensure adequate execution of core quality activities: CAPA, management review, complaint, internal / third party audit, change control, documentation control, validation, traceability, etc.
Bachelor's degree in engineering, science or quality with 10+ years' of relevant work experience (or Master's degree with 8+ years of experience) in a regulated environment, preferably Medical Devices, in Quality in R&D
10+ years' of experience in positions of increasing responsibility supporting large, multi-site, global organizations
R&D quality experience on large scale enterprises in life science industry with significant exposure to requirements of ISO 13485, CFR 820
Self-driven personality with high analytical and conceptual thinking and excellent interpersonal skills
Team player, goal-oriented, with the ability to perform in a complex, global environment
Very good English skills, German is a plus
We can offer you a new challenge, with interesting tasks and much more - including an open corporate culture, flat hierarchies, support for further training and development, opportunities to take on responsibility, an excellent range of foods, sports and cultural facilities, attractive employment conditions, and flexible working time models in various roles.
Helmut Pleiner, Director Corporate Human Resources, is looking forward to receiving your complete application (cover letter, CV, references and certificates) via our online job application platform.
For this vacancy only direct applications will be considered.
+41 58 928 01 01