Job Detail

Senior Quality Manager Research & Development

Inseriert am: 10.11.2020

Who we are


In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we – through our core business brands Phonak, Unitron, Hansaton, Advanced Bionics and AudioNova – develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.


Staefa, CH


Senior Quality Manager Research & Development


Our global quality & regulatory organization starts a journey to come together into one functional, collaborative operating unit. This strong leadership role owns full responsibility of the quality management system of Research & Development (R&D), which covers several locations across the globe.


 


Your tasks


 



  • 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.
     


Your profile


 



  • 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
     


Our offer


 


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.


 


Sonova AG


Laubisrütistrasse 28


CH-8712 Stäfa


+41 58 928 01 01


Sonova is an equal opportunity employer.


We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.

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