Risk Manager Medical Device
Vor 4 Tagen
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.
We are currently seeking a dedicated individual to take on the role of Risk Manager Medical Device. In this pivotal position, you will be responsible for ensuring compliance with Sonova Risk Management processes, both internally and externally, in accordance with regulations and standards such as ISO 14971 and IEC 62304.
Your tasks
Ownership of global Product Risk Management process
Take ownership of our Risk Management Repository in Polarion, ensuring it is regularly updated and improved to reflect the latest standards and best practices
Work towards alignment and harmonization of processes across our growing R&D organization by Identifying and eliminating redundancies, while striving for standardization of Risk Management activities and approaches wherever feasible
Drive continuous improvement initiatives to make our Risk Management processes leaner and more standardized
Conduct training sessions to ensure a consistent understanding of Risk Management procedures, processes, and approaches within our R&D teams
Develop and improve linkages between Product Risk Management and other key processes such as Complaint Management, Post-Market Surveillance, Clinical processes, and various types of FMEAs, facilitating smooth data exchange and collaboration
Assist the Design Quality Assurance team in Design Control and Risk Management activities for assigned projects, ensuring adherence to regulatory requirements and internal standards
Interact proactively with development teams to identify and address deviations early on, minimizing potential risks
Support product improvements, particularly in reliability enhancements, by participating in activities such as FMEAs
Provide support for open CAPAs, Post Launch Changes, Non-Conformances (NCs), and other Quality Assurance activities as required
Assist in internal and external audit programs to ensure compliance with regulatory requirements and industry standards
**Profile**:
University degree in Engineering, Science, Quality and/or a related field of study
10+ years of experience in a regulated environment, preferably Medical Devices, in Quality, in positions of increasing responsibility supporting large, multi-site, global organizations
5+ years of practical experience with Design Control and Risk Management (Hardware & Software)
Knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, 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
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; knowledge of Polarion preferably with expertise in utilizing the Risk Management toolkit would be a distinct advantage
**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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