Quality Assurance Auditor

December 13, 2024

🌽 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

WebsiteLinkedInAll Job Openings

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. • Evaluate Medline suppliers to determine approval status. • Assist in development of Regulatory/Quality Management Systems for potential suppliers. • Manage and participate in quality initiatives to maintain and improve compliance. • Assess compliance risk of systems, facilities, and procedures through audits and assessments. • Plan and coordinate travel for supplier and internal audits, both domestically and internationally.

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. • 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). • Experience with FDA regulations (21 CFR 820, 21 CFR 210/211) preferred. • Experience with ISO 13485 preferred. • Experience in CAPA (Corrective and Preventive Actions) management preferred.

Benefits

• Health insurance • Life and disability insurance • 401(k) contributions • Paid time off