ASTRAMED HEALTHCARE PTE. LTD. is seeking a Global Quality Manager based in Singapore to oversee the Quality Management System (QMS) across Singapore and the U.S., ensuring compliance with various global regulations. The ideal candidate should have extensive experience in quality management within the medical device industry and be bilingual in Chinese and English
Job Summary
This role oversees the Quality Management System across Singapore and the U.S., ensuring strict compliance with ISO 13485, FDA QSR, EU MDR, and MDSAP regulations.
The successful candidate will lead end-to-end quality processes, drive CAPA management, and manage supplier quality while coordinating both internal and external audits.
Based in Singapore with frequent business travel to the United States, this position reports to the Quality Director and requires bilingual proficiency in Chinese and English.
Matching Summary
Match Score: 85
ASTRAMED HEALTHCARE PTE. LTD. is seeking a Global Quality Manager based in Singapore to oversee the Quality Management System (QMS) across Singapore and the U.S., ensuring compliance with various global regulations. The ideal candidate should have extensive experience in quality management within the medical device industry and be bilingual in Chinese and English.
Skills & Requirements
Must-have
ISO 13485 compliance experience
FDA 21 CFR Part 820 knowledge
EU MDR regulatory expertise
MDSAP audit management
Medical device industry background
CAPA and continuous improvement leadership
Nice-to-have
Lead Auditor certification preferred
Ultrasound or active medical device experience
ISO 14971 familiarity
Statistical quality control skills
Entrepreneurial mindset and resilience
Cross-functional communication excellence
Key Requirements
Bachelor's degree in Engineering or Life Sciences
5-8+ years of quality management experience in medical devices
Bilingual proficiency in Chinese and English
Experience with ultrasound or high-complexity MedTech preferred