QA/QMS Engineer
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.
This role will focus as a Quality Representative, QS Quality Improvement Team, Basic QMS Role, Quality Representative QA CSS
What you will do
- Ensure the medical device regulatory compliance for the products released to market. - Support APAC countries with Customer facing activities.
- Screening Sales force case to ensure customer feedback is processed correctly and trends and issues can identified as required.
- To support all APAC regions.
- To closely monitor Sales force cases (and other sources) for new product launches in APAC countries and provide necessary information pre and post launch to country BQ.
- To document and maintain customer return processes for all APAC countries to ensure full transparency.
- To help / coordinate the documentation and maintenance of local Regulatory requirements overview list and follow up / support countries in assessment and action required in cases of changes. This does include local labeling requirements.
- To ensure transparent and clear overview about local (APAC) affiliate requirements to run business (such as manufacturing license / certification requirement as well as customer requirements/ license) and to ensure and ensure data are up to date to avoid any business disruption in alignment with local BQ person in charge.
- Prepare data input for local QIT meetings within APAC affiliates (focus customer related topics) in alignment with local BQ person in charge
- Add Hoc:
- to support local BQ team on site as required. E.g. audit prep etc.
- personal development / training
- Continuous improvement and streamlining of processes across APAC to meet business needs.
What you bring
Experience
- At least 3 years experience in QMS of Medical Device Manufacturer.
- Bachelor's Degree of engineering or related field
Personal competencies
- Good communication skills
- Experience in working with colleagues across APAC (including Japan, Korea, India, China, SG, ANZ, but not limited to the
- Proficient in Microsoft programs (Excel, etc)
- At least 3 years experience working in a team.
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.
- Department
- Quality
- Role
- Business Quality
- Locations
- Biñan
QA/QMS Engineer
Loading application form
Already working at WS Audiology APAC?
Let’s recruit together and find your next colleague.