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Quality Assurance Manager Dosi

Requisition ID:  2188
Location: 

Shanghai, CN

Work regime:  Full-Time
Kind of contract:  Fixed Term Contract China

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

Dosimetry

Dosimetry - Innovative and independent quality assurance solutions

IBA Dosimetry develops meaningful and innovative solutions that give medical physicists the accurate and reliable quality assurance (QA) results they need. Today, more than ever, IBA Dosimetry proudly leverages our independent, scientific background for a deeply human, life-driven mission: protect, enhance, and save lives.

Through cutting-edge innovations, IBA Dosimetry has a long history of advancing Quality Assurance in radiotherapy, proton therapy and medical imaging. IBA believes that three drivers are essential to further innovate QA:

- Independence of Quality Assurance solutions

- Convergence of Machine QA and Patient QA

- Smart synthesis of the four QA solutions

Dosimetry Achievements

- Almost 50 years of dosimetry experience

- More than 12 000 users worldwide

- Offering quality assurance solutions for radiation therapy, proton therapy and diagnostics

IBA Dosimetry website.

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