Senior Auditor QA, Sterilization
Medline Industries, LP
full-time
Posted on:
Location Type: Remote
Location: Illinois • United States
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Salary
💰 $92,000 - $138,000 per year
Job Level
About the 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.
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.
Benefits
- health insurance
- life and disability
- 401(k) contributions
- paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
auditingprocess validationmethod validationsterilization processes
Soft skills
leadershiptrainingconsultingcross-functional collaboration