Job Responsibilities

1. Perform ISO 13485, MDSAP, UKCA, MDR management system audits in accordance with Dekra requirements.
2. Perform Technical Documentation assessment as authorized.
3. Prepare audit documents with good quality and deliver findings to clients to ensure client understanding of the audit decision.
4. Manage certification projects.
5. Ensure timely delivery of scheme management and assessment services.
6. Establish and develop an effective partnership, which secures the commercial relationship and encourages opportunities for business development and client satisfaction.
7. Propagate the company’s image and services to customers.
8. Provide support to operation and sales colleagues for customer maintenance.

Job Requirements

1. Master’s degree above in electrical/ biomedical/computer science or related disciplines.
2. Minimum 4 years’ experience of R&D, manufacturing, RA and QM in active medical device industry
3. Working experience of R&D in AI medical device or medical device software is preferred.
4. Working experience in active implantable medical device or active non-implantable ophthalmologic devices is preferred.
5. Knowledge in ISO 13485, ISO 14971 and regulations eg. MDR.
6. CCAA registered auditor on ISO 9001/ISO 13485 auditor is preferred.
7. Good presentation and report writing skills.
8. Fluent in written and spoken of English and Mandarin.
9. Good interpersonal skills and management skills.
10. Able to work under pressure and travel frequently.

***此岗位是德凯集团（DEKRA SE）在中华人民共和国直接或间接设立的所有公司委托德凯达（上海）投资有限公司发布的招聘信息并提供招聘相关服务，面试成功后将于德凯质量认证（上海）有限公司广州分公司（特殊情况协商调整）建立劳动关系。