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Quality Manager

Company: DSJ Global
Location: Williamsburg
Posted on: August 7, 2022

Job Description:

DSJ Global is currently partnered with a global leader of high quality fiber optical solutions that is looking to add a Quality and Regulatory Manager to their team in Williamsburg, Virginia. Responsibilities: --- Maintain and develop quality management system --- Gain understanding of new regulations, perform gap assessment, and assist with updates to the quality manual, operating procedures, and other documentation to ensure compliance --- Lead external audits by the Notified Body, by the FDA, or other regulatory authorities, and customers --- Assist with maintenance and creation of technical documentation for medical devices --- Prepare and submit FDS product applications and manage product recalls of medical devicesQualifications: --- Bachelor's degree in scientific or engineering related field --- 3-5 years of experience working in quality systems pertaining to ISO 13485, FDA 21 CFR820, EU MDD / MDR --- Preferred experience in the medical device industry

Keywords: DSJ Global, Newport News , Quality Manager, Executive , Williamsburg, Virginia

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