Sr Quality Assurance Auditor - Chicagoland Area

Medline Industries LP

Chicagoland Area, US
Base: $92,000.00 - $138,00.00 annual; bonus/equity...
Not specified (likely hybrid or onsite due to the nature of the role and travel requirements)
Audit fda regulated medical devices
Execute complex supplier quality audits
Apply iso 13485 and mdsap standards
Medline Industries LP is seeking a Senior Quality Assurance Auditor for its Chicagoland area operations, focusing on auditing suppliers and internal divisions for compliance with FDA regulations and ISO standards. The ideal candidate will possess significant experience in quality assurance within the medical device or pharmaceutical sectors and will be responsible for leading complex audits and projects

Job Summary

  • This role involves auditing a broad global supplier base against FDA regulations and ISO standards for diverse product portfolios including medical devices and pharmaceuticals.
  • The position requires leading complex supplier regulatory projects and providing training to internal departments on Quality Management System requirements.
  • Medline offers a competitive total rewards package including health insurance, 401(k) contributions, and paid time off for eligible employees.

Matching Summary

Match Score: 85

Medline Industries LP is seeking a Senior Quality Assurance Auditor for its Chicagoland area operations, focusing on auditing suppliers and internal divisions for compliance with FDA regulations and ISO standards. The ideal candidate will possess significant experience in quality assurance within the medical device or pharmaceutical sectors and will be responsible for leading complex audits and projects.

Salary

Base: $92,000.00 - $138,00.00 Annual; Bonus/Equity: Bonus and/or incentive eligible; Benefits: Health insurance, life, disability, 401(k), PTO

Skills & Requirements

Must-have

  • Audit FDA regulated medical devices
  • Execute complex supplier quality audits
  • Apply ISO 13485 and MDSAP standards
  • Manage CAPA follow-up processes
  • Lead cross-functional regulatory projects

Nice-to-have

  • Experience with USP microbial testing
  • Mentoring junior auditors and QA staff
  • Due diligence for potential acquisitions
  • Process validation and sterilization knowledge
  • Strong written communication skills

Key Requirements

  • Bachelor's degree in microbiology, chemistry, or engineering
  • 4+ years auditing FDA regulated medical devices or pharma
  • 5+ years in senior level quality role within med device/pharma
  • Experience with 21 CFR 820 and 21 CFR 210/211
  • Willingness to travel up to 50% domestically and internationally

Work Rights

Not specified

Tailored Resume

Cover Letter