GE BUSINESS NAME : GE Healthcare
BUSINESS / DIVISION DESCRIPTION : GEHC: Quality/Six Sigma
FUNCTIONAL WORK AREA : Quality
ESSENTIAL FUNCTION / RESPONSIBILITIES:
Management for safety， regulation items in NPI projects
Involve in safety design in product development， verify the safety design output
Arrange 3rd part test for safety certification of product， such as ITS and CCC
Prepare and submit the documents for product registrations， such as SFDA， MHLW， FDA and CE
Ensure timely investigation and evaluation of safety related complaints. Documentation of the investigation， risk assessment， and recommended Corrective Actions
Review customer letters and safety notifications.
Cooperate with global SRE team， to support them to register the imported product in China
Support business during internal and external audits of GEHC QMS
QUALIFICATIONS / REQUIREMENTS:
Bachelors degree or above in engineering， better with Electrical & Mechanical design experience.
Fluent English communication skill in both spoken and written
With Knowledge in International standard (UL， IEC， EN， GB).
High competence， can work in high pressure
Efficient in problem solving， leadership to drive to complete resolution
Team work
DESIRED:
N/A
GENERAL DESCRIPTION:
GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. GE Healthcare‘s expertise in medical imaging and information technologies， medical diagnostics， patient monitoring and life support systems， disease research， drug discovery， and biopharmaceutical manufacturing technologies is helping physicians detect disease earlier and to tailor personalized treatments for patients.
GE Healthcare offers a broad range of products and services that are improving productivity in healthcare and enhancing patient care by enabling healthcare providers to better diagnose and treat cancer， heart disease， neurological diseases， and other conditions. Headquartered in the United Kingdom， GE Healthcare is a $15 billion unit of General Electric Company (NYSE: GE). Worldwide， GE Healthcare employs more than 43，000 people committed to serving healthcare professionals and their patients in more than 100 countries.
GE is an equal opportunity employer.
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