Senior Quality Auditor

Senior Quality Auditor – Lake Forest, IL Fundamental responsibilities include: Carries out duties in compliance with established business policies and procedures. Demonstrates commitment to development, implementation, and effectiveness of applicable quality processes as per ISO, FDA, and other regulatory agencies. Exhibits professional behavior with both internal and external business associates reflecting positively on the company and is consistent with the company’s policies and practices. Maintains awareness of the quality consequences that may occur from the improper performance of their specific job. Performs internal audit schedule for Infectious Disease (ID) Business Unit (BU) and collaborates with other Quality System Auditors to develop and maintain ID BU audit standards and procedures. Engages local site Quality teams in audit program, utilizing qualified auditors/resources to perform cross‑site audits and ensuring annual independent review of each site’s quality system processes. Performs audits, including preparation, conduct, and issuance of final audit report. Assists with quality auditor training program, assessing and developing ID BU auditors through training and mentorship. Supports sites in prioritizing and correcting audit findings, including training, process development, additional directed audits, and providing on‑site support. Supports ID BU leadership as necessary through assigned tasks and projects. Performs third‑party supplier audits for strategic suppliers and supplements RMDx BU site supplier audit programs. Performs other duties and projects as assigned. Required Qualifications Bachelor’s degree in Science, Engineering, pharmaceuticals or equivalent. Minimum 8 years of experience with at least 3 years of Quality work experience in medical device industry, including experience as a Quality Systems Auditor and competent working knowledge of nationally recognized Quality Management System auditing standards and procedures. In‑depth knowledge and ability to apply quality system regulations including QSR, ISO 13485, MDSAP, cGMP Regulations, MDR, IVDR and other regulations and standards relevant to the ARDx business. Preferred Qualifications Certification as a Quality Auditor from ASQ, RAPS, ISO or equivalent. General knowledge of engineering and technical applications applied in development of medical devices. Proficient with MS Word, Excel, Power Point, and management of spreadsheets. Excellent interpersonal, written, and verbal communication skills, including ability to make clear, well‑founded decisions regarding conformity during audits. Ability to travel, including valid driver’s license (60% travel required) and passport. The base pay for this position is $86,700.00 – $173,300.00. In specific locations, the pay range may vary from the range posted. Abbott is an Equal Opportunity Employer, committed to employee diversity. #J-18808-Ljbffr Abbott