Design Quality Assurance Manager

vor 2 Monaten

Zurich, Schweiz Sonova AG Vollzeit

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, Sennheiser, Advanced Bionics and AudioNova - develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.

As Design Quality Assurance Manager, you will ensure compliance of R&D processes, deliverables and documents to regulations, standards and good development practices.

Your tasks

Be part of new product development and post-market engineering activities ensuring that quality assurance requirements are met
Perform required Risk Management activities for Software and Hardware according to ISO 14971 and IEC 62304 in relation to assigned projects to ensure that the benefits of the product outweigh the risks
Support project teams to ensure that products in the pipeline are launched according to project plan, minimizing process deviations
Support design changes
Proactively interact with development teams to identify and avoid deviations
Establish a homogeneous understanding of needed procedures, processes, and approaches within the group R&D
Align and harmonize processes in a growing R&D organization, eliminating redundancies and standardizing processes
Support and initiate product improvements as necessary, particularly regarding reliability enhancements (e.g., supporting FMEAs)
Assist process owners with the creation and maintenance of SOPs (Standard Operating Procedures)
Perform process improvements to enhance efficiency and effectiveness
Support with open CAPAs (Corrective and Preventive Actions), Post Launch Changes, and NCs (Non-conformances) as required
Support internal and external audits as needed

**Profile**:
University degree in Engineering, Science, Quality and/or a related field of study
8+ years of experience in a regulated environment, preferably Medical Devices, in Quality, in positions of increasing responsibility supporting large, multi-site, global organizations
Knowledge of ISO 13485, ISO 14971, IEC 62304, MDR 2017/745
Ability to give presentations to a wide spectrum of audiences
Ability to understand, interpret and explain complex device quality regulations to non-experts
Combination of strong technical background and business acumen
Excellent interpersonal, communication and stakeholder management skills
Proficiency in English, ensuring seamless communication within a diverse, global environment
Good knowledge of the MS Office toolkit
**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. Employment level: 100%.

Sonova AG
Laubisrütistrasse 28
CH-8712 Stäfa
+41 58 928 01 01

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