This is a fully remote position, open to applicants in Illinois.

📋 Description

• Conduct audits across a diverse, global supplier network to ensure compliance with FDA regulations, ISO standards, and other relevant global regulatory requirements.

• Carry out internal audits for Medline divisions and manufacturing facilities.

• Manage intricate and critical supplier regulatory projects that involve collaboration with cross-functional teams.

• Strategically plan, schedule, and perform complex, high-risk supplier audits to assess Quality Management System (QMS) and regulatory adherence.

• Ensure appropriate follow-up on Corrective and Preventive Actions (CAPA) for both supplier and internal audits.

⛳️ Requirements

• A bachelor's degree in microbiology, chemistry, engineering, or a related discipline.

• Minimum of 4 years of experience in auditing FDA-regulated medical devices or pharmaceuticals, or at least 5 years in a senior quality role within medical device or pharmaceutical manufacturing.

• Proficient knowledge of FDA regulations (21 CFR 820, 21 CFR 210/211).

• Familiarity with ISO 13485 standards.

• Experience in process validation, method validation, and sterilization procedures.