Global Quality Process Lead – Complaint & Vigilance

Medline Industries, LP; Mundelein (IL); On-site; USD 92,000 - 138,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a senior quality and regulatory professional to design, implement, and maintain global complaint management and vigilance processes across medical devices, pharma, and related products.

The role focuses on regulatory reporting, investigations, and data governance, supporting cross‑functional teams and global harmonization of quality processes. A bachelor’s degree and 4+ years of relevant experience are required.

Qualifications

• Knowledge of FDA, QSR and ISO requirements, including post‑market surveillance.
• Experience developing and maintaining quality system documentation and governance.
• Experience with complaint/investigation processes and regulated environments.

Responsibilities

• Administer and govern global complaint management and regulatory reporting processes and quality systems.
• Collect, analyze, and report quality data to improve performance and compliance.
• Identify opportunities to harmonize processes and systems for global quality operations.
• Track key quality metrics and ensure adherence to regulatory requirements.
• Support IT systems related to complaint management, vigilance, and coding standards.
• Collaborate with cross‑functional teams to deploy standardized quality processes.

Skills

Regulatory reporting knowledge

Quality systems experience

Post-market surveillance

Education

Bachelor’s degree in science/engineering/healthcare

Tools

SAP

ETQ Reliance

MS Visio

MS Project

Minitab

Job description

Medline Industries, LP is seeking a senior quality and regulatory professional to design, implement, and maintain global complaint management and vigilance processes across medical devices, pharma, and related products.

The role focuses on regulatory reporting, investigations, and data governance, supporting cross‑functional teams and global harmonization of quality processes. A bachelor’s degree and 4+ years of relevant experience are required.