Agnieszka Baczek
Manager Quality @Medline
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WORK HISTORY
Manager Quality @Medline
IL, US
Lead a team of 10 quality and sterilization auditors, providing strategic direction, performance management, and professional development.• Oversee the internal and supplier audit program, including sterilization audits, by establishing and maintaining comprehensive audit schedules aligned with regulatory requirements.• Manage the supplier evaluation and re-evaluation process to ensure ongoing compliance and performance standards.• Develop and deliver auditor training and qualification programs to maintain high standards of audit effectiveness and consistency.• Designed and implemented a risk assessment framework to evaluate supplier performance and prioritize audit activities.• Conduct internal and supplier audits in accordance with FDA, ISO, and other applicable regulatory standards.• Lead CAPA reviews resulting from audit findings, ensuring timely and effective resolution of compliance issues.• Author, review, and approve standard operating procedures (SOPs) to support quality system integrity and regulatory alignment.• Collaborate with global partners to support regulatory compliance initiatives and harmonize quality practices across regions.
EDUCATION
Illinois Institute of Technology
Bachelor of Science, Biomedical Engineering
William Rainey Harper College
Engineering, General
Loyola University Chicago
Master of Business Administration (MBA), Supply Chain Management
ABOUT AGNIESZKA BACZEK
Quality leader with over 12 years of progressive experience across medical devices, pharmaceuticals/API, sterilization processes, and global supplier oversight. Deep expertise in risk‑based quality system design, audit program leadership, and regulatory inspection readiness across FDA, EU MDR, MDSAP, and global GMP requirements.Recognized for converting complex regulatory expectations into robust, data‑driven, and scalable quality processes that strengthen compliance, maintain control of critical processes, and safeguard product quality and patient safety.
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