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 currently hiring for Staff Engineer, Business Quality for our Binan Office in Philippines. The resource will be responsible for ensuring regulating compliance for medical devices, maintain and improve the quality management system in PH, and drive continuous improvement of procedures and processes to meet business needs.
What you will do
Operations Quality
- Lead for all internal and external Operations-related quality issues.
- Coordinate between WSA and IMI to manage quality issues, including product containment, sorting, discussions, and communication with Affiliates.
- Ensure audit readiness and compliance with regulations, standards, and procedures in collaboration with IMI counterparts.
Feedback/Complaint Investigation And Resolution
- Communicate with Operations regarding feedback or complaints related to the Philippine site, ensuring timely and complete resolution of quality issues.
- Review and approve submitted CAPAs for MRNs and customer complaints.
- Serve as an additional investigator in the WSA complaint management system for IMI-related cases requiring further analysis and action plans.
QMS, Regulatory Affairs And Audits
- Support the PH Business Quality Manager with QMS and regulatory affairs, liaising with IMI partners for site/product registrations and external audits.
- Assist in managing the PH site's QIT program and drive continuous improvement of procedures and processes.
What you bring
Experience
- 5+ years of experience in Quality Management in Medical device manufacturing.
- Well versed in 7QC tools, problem solving methodology (e.g., 8D)
- Data analytics background
- Certification in ISO 9001 or ISO 13485
Personal competencies
- Very good communication (written and oral) and presentation skills
- Team player and goal oriented.
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.
