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.
In this role, you will work in a close and collaborative relationship with the NPI project development team to identify early design issue during design transfer. You will be responsible to:
- Track and consolidate POC/FOT/DR3 build material and arrange with production on resources availability. Provide assembly training to operators.
- Establishing procedure(s) to ensure that the new NPI design is translated into production specifications based on FDA 21 CFR 820.30 (h) – Design Transfer requirement. This includes
- Official pFMEA for assembly
- Official product WI (covering proper line balance approach and Chinese translation)
- Process/Software validation and update Master Validation Protocol
- UAT on System process workflow
- Official DMR generation for IPL and ramp-up
- Debugging and investigation on IPL failures and tabulation of IPL reports. Support debug and cause analysis on failures detected during initial ramp-up phase.
- Support engineering activities e.g. evaluation, trial and documentation on 2nd source suppliers qualification and cost saving projects.
The candidate profile
- 3-5 years of experience in Manufacturing /Semiconductor environment
- Experience on product assembly processes, as well as knowledge in Lean/Six Sigma methodologies and related problem solving techniques (i.e DMAIC, Fishbone Diagram, 5 why analysis, etc.)
- Experience in writing protocols for process validation (i.e. IQ, OQ and PQ).
- Familiar with or prior hands on experience in 3D CAD modeling software (i.e. AutoCAD/Pro-Engineer/Solid Works etc.) will be advantageous.
“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”