WS Audiology combines over 140 years of experience in pioneering better solutions to help people with hearing loss. With a passion for impact, our 12.000 employees are committed to achieving our purpose: wonderful sound for all. With brands like Signia, Widex, Audio Service, Rexton and Vibe, and with diverse assets across wholesale, retail, online, managed care and diagnostic solutions, we are active in over 125 markets. Going beyond together, we achieve annual revenues of around EUR 2 billion.
We are looking for a Product Risk Manager with a background in quality management system to join our global product risk management team. You will be responsible:
- Product Risk Manager for WS Audiology product in accordance to ISO14971:2019
- Support of risk management activities for WSA including risk management process/ risk assessment
- Involve in Production and Post-Production Information as part of Post Market Surveillance System
- Role of Product Risk Manager for R&D development projects in Singapore, Erlangen and Lynge including hardware, software and accessories
- Support product risk management related audits (Customer, internal and external)
The Candidate Profile
- 3-5 years of experience in risk management / quality management domain in the medical device / manufacturing industry
- QSR, MDR, MDD, ISO 13485, ISO 14971
- US FDA inspection and ISO 13485 audit experience
- Added advantage to have regulatory affairs knowledge/ experience
- Good communication and interpersonal skills
Join Us and be part of our Quality team!
At WS Audiology, your work matters. We bring back hearing by innovating hearing aids and care to improve the lives of millions. Together, we unlock the potential to impact and define our industry. Will you amplify your life?
We are committed to providing equal opportunities in employment. We do not discriminate against candidates on the basis of race, color, gender, age, national origin, religion, sexual orientation, gender identity or expression, marital status, citizenship, disability, or any other legally protected factor”