Sr. QE Lead

Edison, NJ

Job ID: 120442 Industry: Quality

 

Sr. QE Lead (Change Control)

Environment:

Our client is a large medical device manufacturer.   They are in need of a quality engineer to help with their labeling change management initiative.

Duties/Responsibilities:

The consultant will be responsible for looking at our client’ s labeling processes.  They will be working on the change management, change control, and design control aspects of this initiative.  This person will come in and get a firm understanding of our client’ s current processes/procedures.  A large portion of this project will be analyzing these procedures.  They will then be responsible for identifying where the processes are falling short and will need to re-write/change procedures to make them more efficient.  They will then be responsible for giving procedural guidance/training on the improved procedures.  It would be a big plus if this candidate had training experience.  This person will also have an excellent understanding of QS and the regulations involved.  They will essentially be the change control lead for implementing these new procedures and embedding them into change control.  Someone with a new product development background would be a big plus as well.

This person will be responsible for leading the end to end procedures for this labeling initiative.  They must feel comfortable in a high visibility role and running this process.  Also, since this person will be responsible for bringing cross functional group together, they must have the soft skills/project management skills to do so.

Required:

-Quality Engineering

-Change Management (Change Control, Design Control)

-Medical Device

-Process Design and Change

-Sampling Plan Development

-Excellent Written and Communication Skills

Plus:

-Training

-NPD

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