Senior Quality Auditor

Abbott seeks a Senior Quality Auditor for the Infectious Disease Business Unit in Lake Forest, Illinois. This role develops and executes internal compliance audit programs for diagnostics entities and suppliers, ensuring adherence to regulatory standards and quality management systems.

Responsibilities

• Develop and execute annual internal audit schedule for Infectious Disease Business Unit
• Conduct internal and third-party supplier audits; prepare audit reports and findings
• Collaborate with Quality Systems Auditors to establish audit standards and procedures
• Mentor and train quality auditors through assessment, development, and on-site support
• Support sites in prioritizing audit findings corrections and process improvements

Requirements

• Bachelor's degree in Science, Engineering, pharmaceuticals, or equivalent
• Minimum 8 years experience with at least 3 years in medical device quality
• Demonstrated experience as a Quality Systems Auditor
• In-depth knowledge of QSR, ISO 13485, MDSAP, cGMP, MDR, and IVDR regulations
• ASQ, RAPS, or ISO quality auditor certification (preferred)
• Proficiency with MS Office suite and spreadsheet management (preferred)
• Valid driver's license and passport with ability to travel 50-60% (preferred)

Compensation: $86,700–$173,300 base