JOB SUMMARY:
The Quality Management System (QMS) Manager plays a crucial role in ensuring the compliance, efficiency, and effectiveness of the Quality Management System within Quasar. Reporting to the Director of Quality, the QMS Manager oversees all aspects of the QMS, driving continuous improvement initiatives and maintaining regulatory compliance to meet industry standards and requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Include the following. Other duties may be assigned.
1.Develop, implement, and maintain the Quality Management System in accordance with ISO 13485 and other relevant regulations and standards (e.g. US FDA 21 CFR 820, EU MDR, MDSAP, NMPA etc.)
2. Lead internal audits, corporate audits, and regulatory inspections to assess compliance and identify areas for improvement.
3. Establish and maintain quality objectives, key performance indicators (KPIs), and metrics to monitor the effectiveness of the QMS.
4. Provide guidance and support to cross-functional teams in the development, implementation, and maintenance of quality procedures and processes.
5. Ensure proper documentation control, including the management of quality records, procedures, work instructions, and forms.
6. Conduct risk assessments and participate in risk management activities, including hazard analysis and risk mitigation strategies.
7. Lead and facilitate Management Review meetings to evaluate the performance of the QMS and drive continuous improvement initiatives.
8. Collaborate with other departments, such as Engineering, Manufacturing, Sourcing, Supply chain to ensure alignment of quality objectives and processes.
9. Stay informed about changes in regulations, standards, and best practices relevant to medical devices, and implement necessary updates to the QMS.
10. Provide training and support to employees on quality-related topics, including QMS procedures, regulations, and compliance requirements.
11. Investigate non-conformances, customer complaints, and CAPA (Corrective and Preventive Action) requests to identify root causes and implement effective corrective actions.
12. Serve as the primary point of contact for external auditors, regulatory agencies, and notified bodies during audits and inspections.
13. Drive a culture of quality and compliance throughout the organization, promoting awareness and understanding of the importance of quality in all activities.

EDUCATION/ EXPERIENCE AND QUALIFICATIONS:
1. Bachelor degree in Engineering or Life Sciences or related field; advanced degree preferred.
2. Minimum of 5-10 years of experience in quality management within the medical device industry.
3. In-depth knowledge of ISO 13485 and other relevant regulations and standards (e.g., US FDA QSR, MDSAP, NMPA etc.).
4. Experience lead QMS implementation and maintenance activities, including audits and inspections.
5. Strong analytical skills and attention to detail, with the ability to identify problems, analyze data, and implement effective solutions.
6. Excellent communication (English) and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
7. Proven leadership abilities, with experience in driving continuous improvement initiatives and managing complex projects.
8. Certification as a Quality Auditor (e.g., ISO / ASQ Certified Quality Auditor) is preferred.
9. Familiarity with risk management principles and tools (e.g., PFMEA, DFMEA, HACCP) is desirable.
10. Proficiency in Microsoft Office applications and experience with quality management software systems is a plus.

其他信息
语言要求：英语

所属部门：QA&RA