Medical Device Quality Engineer

Phoenix, AZ

Industry: Medical Device Job Number: 131843


Medical Device Quality Engineer


Our client is a large medical device manufacturer of class 3 devices. They are currently implementing  ISO 13485 2016 and are in need of a seasoned Quality Engineer to support their efforts. They are also preparing for an upcoming audit and will utilize the QE to help prepare.

Duties/Responsibilities/Scope of Work

This person will be responsible for executing tasks in preparation and execution of an ISO 13485 2016 implementation. They must have helped a Medical Device company implement ISO 13485 2016, and be familiar with the standards. They will also assist with efforts centered around ISO 14971 Risk Management and should be familiar with those Health Hazard evaluations. This consultant should understand ISO 13485 2016 (Quality Management Systems, Design and Development, etc.)

This is a true Quality Engineering role that will require a lot of execution. It is NOT a consulting role that will call for extreme guidance to the client, more so just providing crucial support to meet deadlines and provide thorough/quality work.


-          ISO 13485 2016

-          Quality Engineering/Medical Device

Job Type: Contract

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