Senior Manager, Quality Assurance

6 days ago


Chicago, Illinois, United States Tempus Full time
Job Title: Senior Manager, Quality Engineering

Tempus is seeking a highly skilled Senior Manager, Quality Engineering to join our team. As a key member of our quality organization, you will be responsible for ensuring the highest level of quality in our medical devices.

Key Responsibilities:
  • Develop and implement quality policies and procedures to ensure compliance with regulatory requirements.
  • Lead postmarket surveillance activities, including complaint intake and record processing, failure investigations, and adverse event reporting.
  • Collaborate with cross-functional teams to ensure quality is integrated into all aspects of product development and commercialization.
  • Develop and maintain quality metrics and reports to track performance and identify areas for improvement.
  • Provide training and guidance to employees on quality procedures and regulatory requirements.
Requirements:
  • Bachelor's degree in a scientific field and 8+ years of experience in quality assurance or a related field.
  • Master's degree in a scientific field and 6+ years of experience in quality assurance or a related field.
  • 8+ years of experience in a FDA/ISO/IVDD/IVDR regulated environment.
  • Experience in postmarket surveillance and regulatory compliance.
Preferred Qualifications:
  • Subject matter expert in in vitro diagnostic device quality.
  • Deep understanding of reactive and proactive indicators used to monitor and confirm device performance.
  • Skilled oral and written communicator with experience leading through influence across stakeholders.
  • Expert knowledge of device product regulations and standards.

Tempus is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion.



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