Senior Quality Assurance Auditor

Job not on LinkedIn

September 19

🌽 Illinois – Remote

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

💵 $96.2k - $144.6k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Medline Industries, LP

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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.

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 across the full spectrum of Medline products • Perform internal audits of Medline divisions and manufacturing sites • Lead complex, critical, supplier regulatory projects involving cross-functional teams • Act as senior team leader to support Supplier QA Management and facilitate strategic achievement of Supplier Quality goals • Provide training and consulting services to internal departments to understand and comply with Quality Management System requirements • Plan, schedule and execute complex and high-risk supplier audits to evaluate QMS and regulatory compliance • Evaluate Medline suppliers to determine approval status and assist in development of Regulatory/Quality Management Systems for potential suppliers • Conduct CAPA follow-up for supplier and internal audits and write audit reports • Plan and coordinate all travel for supplier and internal audits domestically and internationally • Assist in review and writing of responses to observations issued by FDA or other regulatory agencies and aid in preparation for FDA inspections • Manage and participate in quality initiatives to maintain and improve compliance, create and revise procedures and SOPs • Assess compliance risk of systems, facilities, and procedures per applicable regulations and assist in integration of new acquisitions and perform due diligence audits • Provide mentoring, coaching, and training to junior auditors and assist in managing the rotational QA program

🎯 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 • Detail-oriented, with excellent oral and written communication skills • Ability to listen and process all relevant details, understanding and prioritizing their importance and drawing clear and concise conclusions • 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 • PREFERRED: Experience with USP 61/62 for Microbial Testing of Non-Steriles • PREFERRED: Experience in CAPA (Corrective and Preventive Actions) management

🏖️ Benefits

• health insurance, life and disability • 401(k) contributions • paid time off • bonus and/or incentive eligible • continuing education & training • Employee Assistance Program • Employee Resource Groups • Employee Service Corp