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.

• Execute internal audits for Medline divisions and manufacturing facilities.

• Strategically plan, schedule, and carry out intricate supplier audits to assess Quality Management System (QMS) and regulatory adherence.

• Draft audit reports and convey findings to senior management.

• Offer training and consulting services to internal departments to ensure alignment with Quality Management System mandates.

• Support preparations for FDA inspections and audits by other regulatory bodies for both Medline facilities and suppliers.

⛳️ Requirements

• A Bachelor’s degree in microbiology, chemistry, engineering, or a related discipline.

• A minimum of 2 years of experience in auditing FDA-regulated medical device or pharmaceutical manufacturing or testing, or at least 3 years in a quality role within medical device or pharmaceutical production.

• Meticulous attention to detail, accompanied by strong oral and written communication abilities.

• Proficient in listening to and processing all pertinent information, effectively understanding and prioritizing its significance, and drawing clear, concise conclusions.

• Proven experience in managing and coordinating multiple concurrent projects, with competing priorities and tight deadlines.