Job Description

Are you passionate about ensuring the safety and reliability of life-saving medical devices? At Hologic, we are seeking a Quality Assurance Engineer – Product Quality to play a critical role in managing product holds, stop ships, corrections, and field actions. In this role, you’ll develop and maintain Quality Management System (QMS) procedures, collaborate with cross-functional teams, and drive process improvements to ensure compliance and efficiency. If you’re detail-oriented, proactive, and eager to contribute to the continuous improvement of product quality, this is your opportunity to make a meaningful impact in the healthcare industry.

Knowledge:

  • Strong understanding of Quality Management Systems (QMS) and regulatory requirements, including field action management, product holds, and stop ships.
  • Familiarity with FDA regulations, ISO 13485 standards, and corrective/removal action processes.
  • Knowledge of product lifecycle management ...

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