1. Execute Quality Management System (QMS) processes to ensure compliance with standards such as ISO 13485, IEC 62304, ISO 14971, and ISO 27001. Analyze and propose improvements to QMS processes, and proactively communicate quality issues to cross-functional teams and management.
2. Lead risk management meetings with cross-functional teams, assist in analyzing product risks, and support the development of control measures.
3. Lead the annual quality review meeting and participate in design and development reviews at various stages, as well as design change review meetings.
4. Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve product and quality-related issues.
5. Take the lead in internal and external audit activities.
6. Lead post-market surveillance activities and drive continuous improvement for sustaining products.
7. Maintain document and record management processes in compliance with QMS, ensuring the integrity and timely updates of documents and records.
8. Ensure all products comply with medical device regulations, other applicable laws, company operating procedures, processes, and task requirements. Provide training on quality policies/procedures to project teams when necessary.
9. Foster effective collaboration and communication with employees at all levels, contractors, and suppliers/vendors.
10. Develop and execute regulatory strategies for new and modified medical devices to obtain international market approvals (Taiwan, US, Japan, and Southeast Asia, etc.).
11. Prepare, review, and submit regulatory documentation to ensure timely approval of medical devices, while maintaining compliance with applicable regulations and standards.
12. Manage regulatory submission timelines, track deliverables, and coordinate with internal teams to ensure alignment with company goals and regulatory requirements.
13. Consolidate inputs from the risk management team and develop risk management plans and reports in accordance with ISO 14971, ensuring comprehensive risk assessment and mitigation throughout the product lifecycle.
14. Perform other related duties and responsibilities as assigned
RequirementsRequirements：
1. A minimum of 5 years of experience in quality assurance within the medical device industry.
2. Solid knowledge of current regulations and standards, including QMS, FDA 21 CFR Part 820, (EU) 2017/745 (MDR), ISO 13485, and IEC 62304.
3. Internal audit training qualifications or relevant certifications are required.
4. Demonstrated experience in leading external audits and successfully achieving audit compliance is required.
5. Excellent interpersonal and communication skills, both written and verbal, to effectively communicate across all levels of the organization.
6. Proven ability to work independently as a Quality Improvement Project Lead and manage tasks in a timeline-driven environment.
7. Positive working attitude with strong personal drive, target-oriented mindset, and excellent problem-solving skills, capable of performing effectively under pressure and in a fast-paced environment.
8. Knowledge of global regulations and guidelines related to AI/ML-based SaMD and cybersecurity is a strong plus.
9. Proven experience in procurement and supplier management is preferred.
10. Demonstrated experience in the preparation and submission of US, EU and Japan regulatory filings is a plus.
Required:
1. Education: Master's degree in a relevant field such as pharmacy, life sciences, medicine, biomedical engineering, software engineering or a related discipline.
2. Experience: 5+ years
3. Skills: Internal audit training qualifications or relevant certifications, Technical report writing, Cross-functional team collaboration, Communication across all levels of the organization, Problem-solving
Preferred:
1. Experience in medical device quality assurance, medical device, Biomedical or related background and knowledge is preferred. 2. Be able to write technical documents in Chinese/English and have good Chinese/English email communication skills. 3. Experience in procurement and supplier management is preferred