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Director Of Quality Assurance

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All Star Connections

2021-12-03 08:50:19

Job location Cambridge, Massachusetts, United States

Job type: fulltime

Job industry: Executive Positions

Job description

This permanent opportunity leads all Quality activity for a IVD startup spun-out of a very well respected university. This company will change the speed at which tests are run to be able to get results at POC.


You'll be responsible for driving the development of the company's Quality strategy and policies. This position ensures US and global quality compliance in both a R&D and commercialization environment. This role will initially be tasked with authoring and establishing QMS protocol, then building a team to execute on your QMS protocol.


1)Assumes role of Management Representative to external governing bodies

2)Drive the development of the company's Quality strategy and policies.

3)Drives QA Design and Development efforts of new product development

4)Direct and implement advancement of FDA Quality System Regulations and document hierarchy supporting ISO 13485 and ISO 14971 program

5)Lead quality design and development activities and continuous improvement activities.

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