About this role

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.
Lead complex, critical supplier regulatory projects involving cross-functional teams.
Act as senior team leader to support Supplier QA Management and facilitate strategic achievement of Supplier Quality goals.
Provide training and consulting services to internal departments to understand and comply with Quality Management System requirements.

Bachelor’s degree in microbiology, chemistry, engineering or related field.
At least 4 years of experience auditing FDA regulated medical Device or pharmaceuticals OR at least 5 years working in senior level quality role within medical device or pharmaceutical manufacturing.
Experience with FDA regulations (21 CFR 820, 21 CFR 210/211).
Experience with ISO 13485.
Experience applying knowledge of process validation, method validation and sterilization processes.
Detail-oriented, with excellent oral and written communication skills.
Position requires travel up to 50% of the time for business purposes (within state, out of state and/or internationally).

Senior Auditor, QA

Key skills