Quality Assurance Auditor

March 20

🌽 Illinois – Remote

Although this job is listed in Illinois, this company may be open to hiring remote in other states.

💵 $79.6k - $115.4k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔧 QA Engineer (Quality Assurance)

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Medline Industries, LP

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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.

Manufacturing and distribution of medical supplies • Medical Devices • Supply Chain

10,000+ employees

Founded 1910

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 Private Equity Round on 2021-06

📋 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. • Plan, schedule and execute complex supplier audits to evaluate QMS and regulatory compliance. • Manage and participate in quality initiatives to maintain and improve compliance. • Assess compliance risk of systems, facilities, and procedures per applicable regulations through audits and assessments. • Write audit reports and communicate results to upper management. • Provide training and consulting services to internal departments to comply with Quality Management System requirements. • Assist in the review and writing of responses to observations issued by FDA or other regulatory agencies.

🎯 Requirements

• Bachelor’s degree in microbiology, chemistry, engineering or related field. • At least 2 years of experience auditing FDA regulated medical device or pharmaceuticals manufacturing or testing OR at least 3 years working in quality role within medical device or pharmaceutical manufacturing. • Detail-oriented, with excellent oral and written communication skills. • Ability to listen and process all relevant details, understanding and prioritizing their importance. • Experience developing ways of accomplishing goals with little or no supervision. • Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines. • Position requires travel up to 50% of the time for business purposes (within state, out of state and/or internationally).

🏖️ Benefits

• health insurance • life and disability • 401(k) contributions • paid time off • access to the Employee Assistance Program • access to Employee Resource Groups • access to the Employee Service Corp