Driven by the passion to improve quality of people’s lives, WS Audiology continues to grow as a 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 to reach more people, more effectively.

What you will do

• Observe daily operations and ensure product/process quality meets specifications required.
• Working with IMI-Engineering on Weekly Process/Test Yield Reporting and drive yield improvement to meet KPI.
• Working with IMI-Engineering and Manufacturing to maintain Process flow, Control Plan, PFMEA, Operation and Maintenance with good documentation practice.
• Coordinate and work closely with IMI-Manufacturing to drive and meet daily planned output. Working with IMI to support assets/equipment inventory.
• Ensure all technical documentation and procedures are in compliance with ISO 13485 and FDA CFR 21 820.
• Creation and maintenance of Engineering/Product work instruction to ensure Operative compliance.
• Lead projects and product transfer, test deployment and process validations (IQ, OQ, PQ) until completion.
• Investigate/conduct failure analysis on production and process related issues. Execution of containment and corrective action implementation on non-conforming product.

What you bring

• Bachelor’s degree in electrical/Electronic/Mechatronics Engineering or any related Engineering Field.
• 3 – 5 years of working experience in manufacturing, preferably in Medical Device Manufacturing
• Possess experience in Product Functional and Acoustic testing
• Knowledge of the use of proprietary statistical software (e.g. Minitab, JMP)
• Knowledge of Lean and/or Six Sigma methodologies will be advantageous (e.g. FMEA, Quality Control tool and Failure Analysis technique - DMAIC, Fishbone diagram, 5 why analysis, etc.)
• Familiar with or prior hands-on experience in 3D/CAD modelling software (i.e. AutoCAD/Pro-Engineer/Solid Works etc.) will be advantageous.
• Knowledge of FDA Process Validation Guidance
• Experience with regulatory audit, in either ISO 13485 or FDA CFR Part 820
• Knowledge of cGMP and good documentation practices
• Proficiency in Microsoft Office Tools.

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.