Quality Manager (FDA regulated)

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FDA Quality Manager

A medical device manufacturer in Knoxville, TN is currently seeking a Quality Manager with extensive experience in a manufacturing setting regulated by the FDA. The company is experiencing growth and procuring new equipment, necessitating the Quality Manager’s role in equipment and process validations. The successful candidate will be responsible for training the Quality team on inspections, document control, GMP compliance, and more. Additionally, the Quality Manager will ensure compliance with FDA regulations while overseeing the operations of the Quality Lab.

As the Quality Manager, there will be significant involvement in customer interactions.

This renowned corporation, which operates across multiple locations in the U.S., presents an outstanding opportunity to join a company that is expanding its market share with the introduction of several new products.

Candidates must possess a Bachelor’s degree and a minimum of 3 years of experience in Quality management. ASQ certifications are considered advantageous. Previous experience with FDA audits, interaction with regulatory agencies, and familiarity with ISO certification processes are required.

Relocation assistance is available for qualified candidates.

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