Job Detail

Quality Manager Research & Development

Inseriert am: 09.02.2021

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, Switzerland


Quality Manager Research & Development


Our global quality & regulatory organization starts a journey to come together into one functional, collaborative operating unit. This very influential role owns part of 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

  • Contribute to 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 such as 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 8+ years of relevant work experience (or Master's degree with 10+ years of experience) in a regulated environment, preferably Medical Devices, in Quality in R&D

  • 5+ years’ of experience in positions of increasing responsibility supporting large, multi-site, global organizations

  • Previous proven R&D quality experience on large scale enterprises in life science industry with significant exposure to requirements of ISO 13485, CFR  820 

  • Ability to promote high quality culture within the organization

  • Hands-on, solution orientated attitude and good team player

  • Self-driven personality with high analytical and conceptual thinking, excellent interpersonal and communication skills

  • 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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