Medline Industries, LP

Medline makes #healthcare run better

Senior Auditor QA, Sterilization

QA EngineerQA EngineerFull TimeRemoteTeam 10,001+Since 1910H1B No SponsorCompany SiteLinkedIn

Location

Illinois

Posted

66 days ago

Salary

$92K - $138K / year

Bachelor Degree4 yrs expEnglish

Job 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. • 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.

Job 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

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