Quality Assurance Auditor

October 2

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Medline Industries, LP

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

10,000+

💰 Private Equity Round on 2021-06

Description

• Audit a global supplier base against FDA regulations and ISO standards • Perform internal audits of Medline divisions and manufacturing sites • Plan and execute complex supplier audits to evaluate QMS and regulatory compliance • Evaluate and manage Medline suppliers to determine approval status • Assist in development of Regulatory/Quality Management Systems • Manage quality initiatives for compliance • Write audit reports and communicate results to management • Provide training to internal departments • Assist in reviews of responses to regulatory agency observations • Plan travel for supplier and internal audits

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/test • At least 3 years working in 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 • Experience in CAPA (Corrective and Preventive Actions) management

Benefits

• Health insurance • Life and disability • 401(k) contributions • Paid time off • Employee Assistance Program (for roles under 30 hours)