About this role

Audit a broad, global supplier base against FDA regulations, ISO standards, and other applicable global regulatory requirements.
Plan, schedule and execute complex supplier audits to evaluate QMS and regulatory compliance.
Evaluate Medline suppliers to determine approval status and assist in development of Regulatory/Quality Management Systems.
Manage and participate in quality initiatives to maintain and improve compliance.
Assess compliance risk of systems, facilities, and procedures per applicable regulations.

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.
Position requires travel up to 50% of the time for business purposes.

Auditor, QA

Key skills