Quality Assurance Manager Dosi

Mission

Challenges we trust you with

QA Aspect:

•    Collect and understand NMPA regulations regarding medical device, ensure the internal policy and process on quality management to comply the related law and regulation.
•    Monitor QMS implementation in the plant, ensure to pass the audit from local MPA or other 3rd party;
•    Keep the contact with local MPA to ensure that the business activities to meet the requirements from local MPA;
•    Manage the investigation for the adverse event and incident from medical device according to NMPA regulations; Also manage the recalling issue of medical device.
•    Support to register the new product in local MPA;
•    Coordinate and manage the calibration for all tools to ensure that all of them are calibrated on time; 
•    Organize or Provide training on NMPA regulation or quality management;

QC Aspect:
•    Incoming inspection of raw materials and finished products quality checking 
•    Analyzing and identifying quality issues and root cause, support to follow up the corrective and preventive  actions on the NC issues;
•    Developing and implementing quality improvement plan 

What we value

QA Aspect:

1.    Related major on medical device，inlcuding medical devices, biomedical engineering, mechanics, electronics, medicine, biological engineering, chemistry, pharmacy, nursing, rehabilitation, laboratory science. Bachelor’s degree at least ;
(相关专业：医疗器械、生物医学工程、机械、电子、医学、生物工程、化学、药学、护理学、康复、检验学)
2.    At least 5 years quality and regulation management experiences in the plant of manufacturing medical device ;
3.    Familar with NMPA regulation of medical device, specially on the GMP of manufacturing medical device , with the experience to pass the GMP audit from local MPA;
4.    Have the experience of registering the product in NMPA or local province MPA ;
5.    Know the standard ISO13485, preferred to have the internal auditor certificate on ISO13485;
6.    Fluent in spoken and written English

QC Aspect:

1.Have the experience to do inspection on the components and the product in industrial plant;
2.Can use the general QC tools like caliper, micrometer, multimeter etc. ;

And you also are:

Cherry on the cake

Life at IBA