东莞招聘

RESPONSIBILITIES

The position will be part of the Quality organization located in LiKang Agamatrix.
Primary duties include:

1. Takes the leading role in the Internal Audit Program. Prepare annual internal audit plan, audit checklists, schedule and communicate with Process Owners, conduct and document the audit, follow up on corrective actions and review responses to ensure effective implementation. Summarize and present audit findings to Senior Quality Manager. Build out, train and supervise the performance of a team of internal auditors.
2. Takes the leading role 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.
3. Assist the Senior Quality Manager in all external audit activities conducted by third party or regulatory bodies.
4. Be the main contact person with CFDA regarding local regulation updates and compliance issues, licensing and registration activities. Be responsible for regular self inspection and adverse event monitoring and reporting to CFDA.
5.Conduct training and periodic refresher training in GMP/QSR (21CFR820), ISO 13485 and CFDA GMP requirements to staffs in LiKang strip factory.


QUALIFICATIONS

1. Bachelor degree in any science discipline.
2. Five years or more experience in quality assurance for medical devices.
3. Strong understanding and practical experience in the medical device compliance requirements and regulations, e.g. current GMP/QSR 21CFR820, ISO 13485 and CFDA GMP.
4. Demonstrated competence in performing audits.
5. Strong experience in auditing design controls, design transfer, product validation and manufacturing operations will be a plus.
6. Ability to understand, review and document complex design issues.
7. Ability to effectively communicate technical findings to various subject matter experts.
8. Experience in addressing root cause and corrective actions and have good communication skills to work with process owner of the audit and agree upon the CAPA plan.
9. Ability to work on problems with limited direction.
10. Proficient with MS Office.
11. Excellent analytical and communication skills, both oral and written in English and Mandarin

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。