Medical Device Auditor (Non Active Medical Device) / 医疗器械审核员(无源医疗器械)-北京-02427
This position is responsible for conducting Medical Health Services audit.
1.Perform Non-active medical device audit according to standard requirements, regulatory requirements, internal requirements; Focus on EU mandatory market approval (CE mark) and other applicable international multi-agreement approval, including:
-European Medical Device Directives (MDD);
-Canadian Medical Device Regulations (CMDR);
-Japanese Pharmaceutical Affairs Law (JPAL);
-International quality system standards (e.g. ISO 13485&ISO 9001);
-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.Perform evaluations of regulatory submissions including: Technical File Review (EU MDD/93/42EEC Directives);
3.Bring in potential customer information;
4.Support sales and marketing non-activities in technical issues;
5.Perform other duties assigned by Deputy Manager / Department Manager.
1.Bachelor 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.Ideally minimum 2 years working experience in quality system management;
4.Authorized auditor is a 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.