Manager, Quality Assurance – Audit Sterilization/Micro

Medline Industries, LP

Manager responsible for quality assurance and compliance for medical products at Medline. Leading audits and continuous improvement projects while collaborating with diverse teams.

Posted 6/9/2026full-timeIllinois • 🇺🇸 United StatesMid-LevelSenior💰 $116,000 - $174,000 per yearWebsite

About the role

Key responsibilities & impact

Responsible for managing the quality and compliance for applicable products and processes for assigned department(s).
Ensure quality and regulatory compliance with applicable regulations (e.g. QSR, GMP, ISO).
Lead Internal and Supplier Audits for Medline.
Perform internal audits of Medline divisions and manufacturing sites.
Identify and manage the execution of continuous improvement projects.
Assist the division in product evaluation from a quality assurance and regulatory compliance standpoint.

Requirements

What you’ll need

Minimum 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.
Detail-oriented, with excellent oral and written communication skills.
Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.
Bachelor's degree in Engineering, Science, or Technical Field.

Benefits

Comp & perks

Health insurance
Life and disability insurance
401(k) contributions
Paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

quality assuranceregulatory complianceinternal auditssupplier auditscontinuous improvementFDA regulationsISO 13485QSRGMPproject management

Soft Skills

detail-orientedoral communicationwritten communicationcoordinationprioritizationdeadline management