What You'll Do
Perform remote and on-site audits of medical device quality management systems, ensuring alignment with ISO 13485, EU MDR, and MDSAP requirements. You'll lead audit teams, deliver clear assessment reports, and guide clients through corrective actions. Your role includes planning audit schedules, maintaining compliance with internal policies, and contributing to continuous improvement in audit processes.
Build trusted relationships with clients across Taiwan, supporting them in regulatory understanding and quality system enhancement. You'll act as a representative of the organization, promoting best practices and supporting business growth through technical insight and professional integrity.
Collaborate with internal teams to ensure accurate documentation, timely reporting, and effective client follow-up. You'll also mentor junior auditors, contribute to team development, and maintain up-to-date knowledge of evolving medical device standards.
Requirements
- Hold a bachelor’s degree or higher in a field related to medical devices or a relevant technical discipline
- Possess at least five years of experience in quality or technical management within the medical device sector
- Demonstrate hands-on expertise in microbiology, particularly in sterile product manufacturing
- Show strong understanding of ISO 13485, EU MDR, and related regulatory frameworks
- Have direct experience with absorbable, biologically active, or active implantable medical devices
- Display strong analytical abilities, attention to detail, and a results-oriented mindset
- Be comfortable working independently, managing time efficiently, and meeting deadlines under pressure
- Be willing to travel frequently within Taiwan and occasionally internationally
- Be eligible for local employment in Taiwan
Benefits
- Access to comprehensive training programs, including ISO 13485 Lead Auditor, MDSAP, and MDR courses
- Opportunities for international travel to the USA and Europe
- Support in becoming a recognized technical expert and trusted advisor to clients
- Opportunity to contribute to global quality and safety standards in healthcare
- Work in a values-driven environment focused on ethical practices and continuous improvement
