II. Job Responsibilities

1. Perform ISO 13485, MDSAP, UKCA, MDR management system audits in accordance with Dekra requirements.
2. Perform Technical Documentation assessment according to MDR 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.

III. Job Requirements

1. Bachelor’s degree or above in biomedical engineering, biology, biotechnology, medicine, materials and other medical device related majors.
2. Minimum 4 years working experience of R&D, manufacturing, RA or inspection in industries in the field of non-active medical devices.
3. Sterilization experience and microbiologist is preferred.
4. Knowledge in the medical device industry including ISO 13485, ISO 14971 and regulations.
5. CCAA registered auditor on ISO 9001/ISO 13485 auditor is preferred.
6. Good communication and writing skills.
7. Fluent in written and spoken of English.
8. 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。