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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