Main Job Responsibilities:
1) Implement and follow up corporate QMS procedures and instructions;
2) To plan and perform QMS internal audit, follow up NC status;
3) Responsible for relevant QMS database (Internal audit, QMS9000) management, training, implementation and status report;
4) Plan and perform QMS documentation management training/re-training, including implement training and make evaluation;
5) Continuous ensure competence of internal auditor team, including enough auditor resource, competence and training;
6) Timely collect related GB/YY standard and follow up internal document update;
7) Responsible for regulation refresh training and evaluation;
8) Support QEHS external audit and follow up NC status;
9) Support internal QEHS improvement projects and EHS internal audit plan creation.
10) Local administrator of QMS9000, Configuration, SiC and Meridiam database;
11) Support on product registration issue in Zhuhai &Guangdong FDA as required.
12) Responsible for critical service and non-BOM material process owner.
1) University degree with major in chemistry/ food/ pharmaceutical;
2) Minimum 2~3 years of experience as Quality System Engineer or similar position;
3) Experience in Medical Device or chemistry industry is preferred;
4) Good knowledge and sound experience in ISO13485, knowledge and experience in ISO 9001 QMS management system is preferred;
5) Fluent English language – speaking and writing;
6) Good computer skills, familiar with MS office software;
7) Passionate and strong teamwork spirit.