Quality Assurance Auditor

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 Apply Job!