Job Responsibilities

1. Assist in the establishment, supervision and implementation of quality management system, including the establishment and implementation of quality system norms and procedures; Identify the applicable provisions of medical device regulations in the enterprise; 2. Responsible for the company's internal audit, including the preparation of internal audit plan, organization of internal audit implementation, rectification of non-conformance items, etc.; 3. Assist in organizing the company's management review, including the preparation of management review plans, meeting organization, collection of review materials, tracking and verification of non-conformance items, etc.; 4. Responsible for CAPA management, including the implementation, tracking, verification and statistics of CAPA, and convened the review meeting of system nonconformance; 5. Manage and file related documents of quality system, including collection, update and implementation of internal quality management system documents and foreign laws and regulations of medical devices; 6. Responsible for the audit and contact of external audit institutions, and the organization work of welcoming the audit; 7. Responsible for coordination of product registration process, including: making registration plan, assisting product clinical work, organizing preparation of registration materials, registration application and registration maintenance, progress tracking, etc.; 8. Responsible for the handling and maintenance of medical device related licenses (production license, business license, export sales certificate and free sales certificate, etc.); 9. Communicate with competent Authority for regulatory compliance checks and coordinate adverse events, recalls and other related matters; 10. Complete other tasks assigned by superior leaders.

Job Requirements

1. Master degree or above, major in mechanical, electronics, quality management or related; 2. At least 4 years working experience, at least 2 years working experience in ISO13485/ISO9001 quality management system; 3, Familiar with medical device related standards, regulations and policies is preferred; 4. German B2, English IELTS 6.0, literature retrieval ability and English/German document writing ability; 5, Chinese，base Germany, cheerful, honest, proactive.

Required Languages

English, German