Quality Assurance Program Manager

2 weeks ago


Green Oaks, Illinois, United States Abbott Full time

Position Overview

This role is integral to the Quality and Regulatory division at Abbott, focusing on the management of external evaluations concerning Abbott's Quality System. The Quality Assurance Manager is responsible for leading initiatives related to inspection readiness, offering strategic direction and project oversight in support of various business units, and providing expertise in quality and regulatory matters.

As the Quality Assurance Manager, you will be at the forefront of preparing for, managing, and responding to regulatory inspections across multiple sectors within Abbott.

Key Responsibilities

  • Direct the establishment of a comprehensive Inspection Readiness Program across Abbott.
  • Collaborate with various business units to ensure thorough preparation, execution, and follow-up for third-party evaluations.
  • Offer expert guidance during third-party evaluations, focusing on issue identification, facilitation of inspections, and training initiatives.
  • Evaluate compliance levels and the effectiveness of management teams in relation to quality standards.
  • Organize project activities and timelines for various sub-teams.
  • Analyze and recommend solutions for critical issues utilizing risk management strategies.
  • Stay informed about new regulations that may affect Abbott's operations.

Qualifications

  • Bachelor's degree in a scientific or related field.
  • Four-year degree in a technical or scientific discipline.
  • Proven experience with regulatory inspections.
  • Familiarity with quality systems and regulatory frameworks.

Desirable Skills

  • Capability to act as a Technical Advisor or Subject Matter Expert.
  • Strong engagement with senior management on various projects.
  • Experience in managing inspections and understanding regulations.


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