Senior Auditor, QA

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🔥 20 hours ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $92k - $138k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Medline Industries, LP

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1910

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 Private Equity Round on 2021-06

Healthcare Insurance • Pharmaceuticals

Medline Industries, LP is a leading healthcare company that focuses on improving clinical, financial, and operational outcomes for its customers. The company offers a wide array of over 335,000 medical products and boasts extensive warehousing capabilities with more than 28 million square feet of space. With a significant global presence of 43,000 employees, Medline provides agile and scalable solutions across all points of care, achieving a 95% next-day delivery rate within the US. The company's mission is to enhance healthcare delivery by providing superior products, supply chain resilience, and clinical expertise, all while fostering strong customer relationships through tailored, problem-solving solutions.

📋 Description

• Audit a broad, global supplier base against FDA regulations, ISO standards, and other applicable global regulatory requirements. • Perform internal audits of Medline divisions and manufacturing sites. • Lead complex, critical, supplier regulatory projects involving cross-functional teams. • Plan, schedule and execute complex and high-risk supplier audits to evaluate QMS and regulatory compliance. • Conduct adequate CAPA follow-up for supplier and internal audits.

🎯 Requirements

• Bachelor’s degree in microbiology, chemistry, engineering or related field • At least 4 years of experience auditing FDA regulated medical Device or pharmaceuticals OR at least 5 years working in senior level quality role within medical device or pharmaceutical manufacturing. • Experience with FDA regulations (21 CFR 820, 21 CFR 210/211). • Experience with ISO 13485. • Experience applying knowledge of process validation, method validation and sterilization processes.

🏖️ Benefits

• health insurance • life and disability • 401(k) contributions • paid time off