Business QA Manager

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.

Ihre Aufgaben

At WS Audiology, we are dedicated to the continuous growth of our company and the enhancement of our procedures and processes, all in alignment with business objectives. Join us and champion medical device regulatory compliance for products in the market while driving excellence in our quality management system in Singapore. As the local Management Representative, you will uphold our commitment to quality and regulatory standards.

What you will do

• To lead SG Business QA department - develop training plans for the local team and manage local budget and resources.

• Act as the local Management representative.

• Implement and maintain Group Quality policies while providing feedback on process alignment with business needs.

• Oversee local Quality Management System (ISO13485 / 21 CFR Part 820) and handle local CAPA, Document Control, and Training.

• Manage audits (internal, external, customer, third-party, authority) and inspections.

• Resolve customer complaints due to local process issues and provide support for order entry, case management, and local retail.

• Ensure local product quality, NPI, and compliance and assist in NPI and complaint investigations.

• Support Supplier Quality Management, incoming inspections, and change control.

• Participate in local projects, including SMART LEAN.

• Assist with local product registration and regulatory inspections.

• Ensure compliance with local product labeling requirements.

Ihr Profil

• At least 5 years of relevant experience with Medical device background.

• Minimum qualification of Bachelors Degree.

• Experience in ISO13485 and US FDA regulation such as 21 CFR 820.

• Capable of driving independent topics on site with business focus by ensuring regulatory and group policies are met.

• Leadership experience is required; Business / customer oriented job experience/knowledge/mindset.

• Excellent communication skills and possess a high level of stakeholder management.