Driven by the passion to improve the quality of people’s lives, WS Audiology continues to grow as the 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.
Join our Business Quality team as a QMS Specialist based in our Singapore office at Tai Seng. You will play a crucial role in ensuring medical device regulatory compliance for products released to the market and oversee Singapore quality management system maintenance and continuous improvement initiatives.
What you will do
- Document controlImplement and coordinate local Document Control according to internal and legal requirements, such as ISO 13485.
Ensure adherence to global documents while minimizing local documents, ensuring they align with global standards.
Participate in and moderate local change board meetings.
Train and consult team members on Good Documentation Practices (GDP) and process requirements.
Conduct local meetings to inform stakeholders about document revisions or new releases.
Maintain a local overview of Quality Management System (QMS) documents, including archiving and revision control.
Track QMS Change Requests and perform reviews and approvals of revisions or new documents.
- Quality Improvement TeamCoordinate and support local Quality Improvement Teams (QIT), acting as the QIT leader.
Document and archive input from Quality Improvement Team Meetings.
Follow up on action items resulting from Quality Improvement Team Meetings.
- Quality Representative (QS)Prepare and coordinate local Management reviews.
Act as a Quality Management (QM) Auditor, conducting internal audits.
Establish, consult, and train management and employees on the Quality System.
- Local Training OfficerImplement the training concept locally based on global requirements, additional regulatory requirements, and ISO 13485 standards.
Train administrators on the training tool.
Maintain data alongside administrators and update the training matrix in case of revisions.
Track training status, monitor Key Performance Indicators (KPIs), and perform data analysis.
Archive quality-relevant training records as needed.
- Local Audit ManagementServe as the main contact person for all internal and external Quality Management System (QMS) audits in Singapore.
Coordinate, prepare, and follow up on audits, aligning plans and agendas with auditees and auditors.
Coordinate logistical aspects, including organizing facilities and following up on audit findings and improvements.
- Ad HocSupport APAC countries on Doc. Control, Training, Product Registration
What you bring
- 3 years of relevant experience in QMS within the Medical Device Industry
- Eagerness and willingness to learn, demonstrating a proactive approach to professional development.
- Team Player and ability to perform effectively under pressure delivering high-quality results even in challenging situations.
- Internal Auditor Qualification
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.
