无源医疗器械审核员(医疗健康服务部)-北京-07972

Job Responsibilities

1.Perform non-active medical device audit according to standards, regulatory requirements, internal requirements; Focus on EU mandatory market approval (CE mark) and other applicable international multi-agreement approval, including: 80%

-International quality system standards (e.g. ISO 13485 & ISO

9001);

-European Medical Device Directives (MDD) and MDR

-as well as internal Notified Body and TüV SüD America criteria including all related tasks, such as planning, reviewing corrective actions, preparing reports and audit documentation for submission to the certification committee of the Notified Body;

2.Attending training required by MHS and CCAA; 5%

3.Applying for and maintaining auditor’s authorization; 5%

4.Bring in potential customer information; 2 %

5.Support sales and marketing activities in technical issues; 3%

6.Perform other duties assigned by Section Manager / Department Manager; 5 %

Job Requirements

1.Bachelor’s degree or above in scientific field (Microbiological, pharmaceutical, organic and inorganic material, machining, chemical etc).

2.Minimum 5 years working experience in the fields of medical device design, quality control, regulatory clinical, project management and manufacturing;

3.2 years working experience in quality system management is preferred;

4.Authorized auditor is best (CCAA 9001 authorized auditor)

5.Good understanding and fulfillment to working related targets, standards, policies, procedures and instructions;

6.Respect and safeguard company’s image, reputation and benefit;

7.Diligence, self-motivation, self-improvement and strong teamwork spirit;

8.Good communication and interpersonal skills;

9.Can work independently and efficiently; can work under pressure;

10.Good computer skill;

11.Good command of English (written-fluent, oral-medium);

12.Physical condition allows normal working, stable outputs and frequent business trip as required.