Quality Assistant Manager, Taiwan and Hong Kong

Join this team as a Quality Assistant Manager, where you will play a vital role in overseeing and ensuring the effective implementation of quality systems, policies, and procedures. This position involves close collaboration with stakeholders in Hong Kong and Taiwan, as well as the regional Quality Assurance (QA) team, to support compliance with Corporate standards, ISO 13485, and local regulatory requirements.

Responsibilities:
• Oversee supplier quality management, including 3PL and distributor compliance, in both Hong Kong and Taiwan.
• Actively participate in audits and inspections, including regulatory, corporate, internal, and external reviews, and contribute to corrective and preventive action (CAPA) planning and responses.
• Investigate quality concerns in partnership with cross-functional teams and develop resolutions.
• Manage product complaints and related activities, such as adverse event reporting, product holds, field action coordination, and post-market surveillance processes.
• Provide periodic updates on quality metrics and highlights to the Regional QA team.
• Offer innovative solutions and recommendations to improve quality processes, efficiency, and adherence to regulatory and organizational standards.
• Foster collaboration and knowledge-sharing within the QA/RA teams and across departments, building strong cross-functional relationships.
• Partner with Hong Kong QA on Quality Management System activities and supervise post-market surveillance in Hong Kong.
• Undertake additional quality-related assignments as directed by the Senior QA Manager based in Singapore.

Requirements:
• Bachelor's degree in a medical, healthcare, or related field.
• Strong understanding of ISO 13485, Taiwan MDGDP, and Medical Device Act requirements.
• Extensive experience in quality management within the healthcare sector, ideally in multinational pharmaceutical or medical device organizations.
• At least 8 years of experience in the medical device industry, with a focus on commercial or distribution operations.
• Certification as an internal auditor for ISO 13485 or equivalent qualifications.
• Experience in Hong Kong QA processes is highly desirable.