QA/RA Manager

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Published: March 05, 2019
Job Summary: Establish, maintain and improve quality management system to ensure the effective operation and continuous improvement of the quality management system.

Key Responsibilities:-Establish, maintain and improve quality management system to ensure the effective operation and continuous improvement of the quality management system;
-Drafting, the revision and review the quality management system related documents on an ongoing basis;
-To be familiar with regulation terms and implement standards accurately;
-To take part in the preparation and implementation of registering project (such as: MDML)
-To deal with registered matters according the registered regulation.
-To keep good relationship with government.
-To provide consulting and training about registering regulation with relevant people in company.
-Responsible for product registration and other external affairs.
-Other task assigned by supervisor

Requirements:

-Bachelor degree¡Aclinical medical/biological engineering related;
-Certified with internal quality inspection
-5 years or above medical equipment company QA management experience;
-Familiar with ISO13485 standards and QA working process, provide quality audit and training work experience;
-Good English, skilled in MS office software;
-Experience with medical equipment product registration work