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

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