Quality Manager (m/f)

REFERENZNUMMER:

290603/1

IHRE AUFGABEN:

-Ensure human factors considerations are embedded into the design of GBF MD products (devices and software)
-Apply human factors regulations and standards
-Train and support GBF MD project teams regarding human factors
-Perform early review of user interfaces, instructions for use and training material
-Contribute to the design risk management process
-Lead the development of human factors risk management reports and usability specifications
-Organize and lead human factors exploratory testing
-Contact point for question or training on human factors
-Coordinate human factors validation
-Develop/maintain network of human factor experts
-Identify, assess and lead the implementation of new or updated human factors regulations or standards
-Work with human factor testing laboratories
-Define human factor validation strategy
-Contribute to human factors report (US, FDA)

IHRE QUALIFIKATIONEN:

-Experience in medical device industry
-Fluency in English
-Knowledge in Ergonomics/Human Factors Engineering/FDA/notified bodies Risk Management
-Medical Devices Directive, IEC 62304, ISO13485, IEC 62366, 510k, CFR820 and FDA submission

WEITERE QUALIFIKATIONEN:

Quality manager