Formed in 2019, through the merger of Sivantos and Widex, WS Audiology combines over 140 years’ experience in pioneering the use of technology to help people with hearing loss hear the sounds that make life wonderful. We are active in over 125 markets and employ 11,000 people worldwide. Our broad portfolio of hearing related products and services generates annual revenues of around EUR 1.7 billion.
Learn about us on www.wsa.com
This team is part of R&D. System engineering is taking care about high level requirements and concepts considering dependencies of building blocks. This guidance is the input to many departments such as Signal Processing, ASIC, HW, Firmware, Fitting Software, etc.
By its nature, it’s addressing system complexity, performance and interoperability.
A crucial consideration of the overall as well as sub level systems is Basic Safety and Essential Performance.
In this role you will have the following responsibilities:
- Global owner of Basic Safety and Essential Performance
- Drive harmonization within WSA (ex- Sivantos, ex-Widex) to comply with IEC 60601-2-66 (particular standard for hearing aids based on IEC 60601-1)
- Update concept and process of Basic Safety and Essential Performance
- Maintain work instruction and templates
- Continuous follow up with Regulatory Affairs
- Continuous follow up with homologation managers in terms of required certificates
- Translate standard into product requirements
- Provide support to product development
We expect you to have fundamental experience in the field of (Basic Safety) Quality Management. Ideally, you have some know-how how to handle medical products according to applicable standards, already.
You are a team player, who can drive topics but seeks feedback and engage in constructive discussions with your colleagues. Creativity, attention to detail, and a collaborative attitude are part of your strengths.
You most likely fit the following profile:
- completed university degree in engineering
- minimum three years of work experience in a relevant field
- pragmatic nature and focus on efficient implementations
- keen on networking
- well-founded English skills
Join WS Audiology
Please submit your CV as soon as possible. We will screen and invite candidates for interviews on an ongoing basis.