Driven by the passion to improve quality of people’s lives, WS Audiology continues to grow as market leader in the hearing aid industry. With our commitment to increase penetration in an underserved hearing care market, we want to accelerate our business transformation in order to reach more people, more effectively.
We are looking for a Senior Process Engineer to develop and enhance processes using Six Sigma, ensuring compliance with ISO 13485 and FDA standards, and support quality investigations.
What you will do
- Develop robust process by establishing process control through Six Sigma methodologies approach:
- Process Characterization (Input Variable and Response Variable)
- Establish FMEA, Control Plan and Statistical Process Control
- Ensure compliance to Production & Process Control i.e. PFMEA, EHS risk assessment, Validation (IQ, OQ & PQ) and Work Instruction update
- Ensure all technical documentation and procedures are in compliance with ISO 13485 and FDA CFR 21 820
- Support investigation/ failure analysis on ECM operations product and process related quality issues
- Maintain and update operation workflows (MES), work instructions and SMT component placement list/ drawings
- Support alternate/ 2nd source component qualification for engineering trial and implementation of other strategic goals.
What you bring
- Bachelor Degree in Mechanical/ Mechatronics/ Electrical/ Electronic Engineering
- Minimum 5 years of relevant working experience in medical device/ electronics/ semiconductor manufacturing environment
- Must have knowledge and experience in SMT/ PCBA manufacturing processes
- Must have experience in performing process characterization and/ or process validation (IQ,OQ,PQ)
- Knowledge in Lean and/ or Six Sigma methodologies statistical software and process simulation tools (i.e. MINITAB, JMP, etc.)
- Knowledge in ISO 13485 and FDA CFR 21 820 is preferable
- IPC 610 and Six Sigma knowledge/ certification is advantageous.
Who we are
At WS Audiology, we provide innovative hearing aids and hearing health services.
Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world.
With us, you will become part of a truly global company where we care for one another, welcome diversity and celebrate our successes.
Sounds wonderful? We can't wait to hear from you.
WS Audiology is an equal-opportunity employer and committed to creating an inclusive employee experience for all. Regardless of race, color, religion, national origin, age, sex, gender, gender identity, gender expression, sexual orientation, marital status, medical condition, ancestry, disability, military or veteran status we firmly believe that our work is at its best when everyone feels free to be their most authentic self.
