Quality Assurance Auditor
Job Description
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:
Bachelors 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