Senior Quality Compliance Manager

Medline Industries, LP

. Provides senior‑level Quality leadership focused on the governance, execution, and continuous improvement of the Quality Management System (QMS) .

Posted 5/5/2026full-timeNorthfield • Illinois • 🇺🇸 United StatesSenior💰 $134,000 - $201,000 per yearWebsite

About the role

Key responsibilities & impact

Provides senior‑level Quality leadership focused on the governance, execution, and continuous improvement of the Quality Management System (QMS)
Owns divisional QMS activities supporting post‑market surveillance, complaint handling and investigations, CAPA and SCAR management, supplier quality monitoring, risk management
Leads QMS execution across data monitoring, trending, and management review inputs
Drives corrective actions and systemic improvements through structured analysis of post‑market and supplier quality data
Establishes and maintains inspection‑ready QMS processes, procedures, and records
Sets operational priorities and oversees resource allocation for QMS activities
Partners cross‑functionally to ensure sustained compliance and effective system performance

Requirements

What you’ll need

Bachelor’s degree in Engineering, Science, or Technical Field
At least 5 years of experience related to the design/operation of medical device or drug combination product platforms
At least 2 years of management experience
Depth of technical knowledge of relevant standards and regulations (21CFR 820, ISO 13485, ISO 14971, MDSAP, MDR)
Proficiency in analyzing and reporting data and performing statistical analysis
Advanced skill level in Microsoft Excel
Position requires travel up to 30% of the time for business purposes

Benefits

Comp & perks

health insurance
life and disability
401(k) contributions
paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Management System (QMS)post-market surveillancecomplaint handlingCAPA managementSCAR managementsupplier quality monitoringrisk managementdata analysisstatistical analysisMicrosoft Excel

Soft Skills

leadershipcross-functional collaborationresource allocationoperational prioritization