Medical Device Interim Quality Assurance Manager

Fort Myers, FL

Job ID: 126543 Industry: Med

 

Medical Device Quality Assurance Manager

Environment:

Our client is a Medical Device company that manufactures and markets durable/finished medical device goods. They are currently in need of an experienced Quality Assurance professional to act as an interim manager and provide oversight to full time employees/contractor resources. There is a great deal of remediation activity going on in other groups, and this role would entail sustaining Quality Assurance activity in areas outside of that activity.

Principle Duties and Responsibilities:

This consultant should come from a strong, seasoned background in the Medical Device industry with a strong focus on Quality Assurance. Our client is looking for a highly motivated individual to oversee a team of full time employees and contractors who sustain Quality Assurance activity for the company. This person would be overseeing the Quality Management System for the company, which includes  complaint handling, CAPA, internal auditing, device inspection and release, all equipment calibration and supplier quality assurance related activity. The consultant would also lead several Quality Engineers as they develop product development practices in adherence to all design assurance/control methods. All of  these activities will be expected to be carried out by the consultant, while doing so in a highly communicative and high energy manner.

Required:

·  Extensive Medical Device Background

· Experience  in Quality Management position

- Understanding of all aspects of Medical Device Quality Management Systems

- Upbeat and motivated personality, great communicator and organized individual

- Plant experience (manufacturing facility)

Plus:

· Remediation environment

- Finished Goods

-   ISO 13485, MDD, CMDCAS

Job Type: Contract 

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