Director of Quality Assurance and Compliance

20 hours ago


San Diego, California, United States Sekisui Diagnostics, LLC Full time

About the Role:

As a Director of Quality Assurance and Compliance at Sekisui Diagnostics, LLC, you will play a critical role in ensuring the quality and integrity of our products. You will oversee the development, implementation, and maintenance of quality assurance systems and activities, including the generation and review of documents used in good manufacturing practices.

Key Responsibilities:

  • Oversee the development, implementation, and maintenance of quality assurance systems and activities.
  • Monitor audits of production and quality control areas.
  • Audit raw material vendors and prepare manufacturing documentation for updated filing.
  • Coordinate interdepartmental activities.
  • Lead investigations and resolve potential product quality issues to improve efficiency.
  • Select, develop, and evaluate personnel to ensure the efficient operation of the function.

Requirements:

  • 10+ years of experience in the IVD (reagent and/or instrumentation) industry.
  • Thorough knowledge of FDA QSR, ISO 13485, and MDSAP.
  • Strong experience in Firmware, Hardware, and Software Engineering.
  • Experience supporting the realization of new products through new product development, third-party manufacturers, and/or mergers and acquisitions, including oversight of Design Controls.

About Us:

Sekisui Diagnostics, LLC is a leader in in vitro diagnostics, helping improve patient outcomes by innovating and developing highly accurate diagnostics tests, reagents, and systems. We are committed to a diverse workforce and offer competitive compensation, including an anticipated base salary of $185,000-215,000, annual incentives, and comprehensive benefits.



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