东莞招聘

RESPONSIBILITIES

This position will be responsible for administering all documents necessary to define product configuration and control manufacturing processes according to procedures defined in the Company’s Quality System. The Documentation Systems Administrator shall ensure that all users have the latest revision of appropriate documentation and all obsolete documents are retrieved in a timely manner. Primary duties include:

1. Perform duties as defined in document control policies and procedures.
2. Perform administrative duties, as necessary.
3. Review change orders for correctness and completeness and implement them.
4. Provide documentation support, assistance and training to other departments.
5. Work on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required.
6. Review documents for accuracy, proper format, and basic Quality/Regulatory compliance (21CFR820/ISO13485).
7. Monitor and track the review, approval and distribution of documents to ensure timely completion.
8. Collect and maintain files of the latest revision level documentation necessary to define product configuration and control manufacturing processes.
9. Timely distribution of latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from distribution.
10. Develop and maintain a computer database of all filed documentation that ensures good traceability and fast retrieval of documents.
11. Perform clerical typing duties to generate documents as necessary.
12. Work with other departments to ensure uniformity and consistency.
13. Identify opportunities for process improvement.
14. As resident expert in Omnify (PLM software) and perform new employee training and periodic refresher training to staffs in LiKang.
15. Assist the Senior Quality Manager in the establishment and maintenance of the Quality System and operating procedures to assure alignment with current GMP/QSR (21CFR820), ISO 13485 and CFDA GMP requirements.
16. Maintain company training records.


QUALIFICATIONS

1. Bachelor degree in any science discipline.
2. 3-5 years document control experience, preferably in the medical device industry.
3. Knowledge of documentation control requirements for medical device manufacturing (21 CFR 820/ISO 13485).
4. Experience with electronic documentation management systems preferred.
5. Understanding of BOM structure.
6. Proficient with MS Office.
7. Excellent analytical and communication skills in English and Mandarin, both oral and written.
8. Strong interpersonal skills and ability to work with others in a positive and collaborative manner.
9. Excellent organizational and prioritization skills.

厂房面积超过8千平方公尺, 并拥有行业全套先进生产设备, 主要生产设备均由美国进口。

公司福利：
1、公司免费提供早餐、午餐、晚餐（午、晚餐为三菜一汤）。
2、公司为夜班员工提供相应的夜班补贴。
3、公司免费提供住宿，水电费全免。
4、职员每周五天8小时制。
5、工资发放准时，全员社保。