Global Quality Process Lead, Complaint & Vigilance

Medline; Chicago (IL); On-site; USD 92,000 - 138,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline is seeking a quality process design leader to govern global complaint management, investigations, vigilance, and regulatory reporting processes. You will ensure data integrity, coding standards, and system controls across medical devices, pharma, biologics, cosmetics, and supplements.

You will collaborate with Quality, Regulatory Affairs, IT and Operations, driving harmonization, audits support, and continuous improvement in post-market surveillance and quality systems.

Qualifications

• Bachelor’s degree in a scientific, engineering, healthcare, or related technical discipline.
• Minimum 4 years of experience in medical device or pharmaceutical quality, complaint management, or related regulated processes.
• Knowledge of FDA, QSR, ISO requirements and quality system principles.

Responsibilities

• Administer and support governance of global complaint management and regulatory reporting processes.
• Analyze quality data and report performance and compliance.
• Identify opportunities to improve processes, systems, and data quality across global operations.
• Collaborate with cross-functional teams to deploy and integrate quality processes and IT systems.
• Support audits, inspections, CAPA, and change management initiatives.

Skills

Quality process design

Regulatory knowledge

Data analysis

Education

Bachelor’s degree in science/engineering/healthcare

Tools

MS Visio

MS Project

Minitab

Job description

Medline is seeking a quality process design leader to govern global complaint management, investigations, vigilance, and regulatory reporting processes. You will ensure data integrity, coding standards, and system controls across medical devices, pharma, biologics, cosmetics, and supplements.

You will collaborate with Quality, Regulatory Affairs, IT and Operations, driving harmonization, audits support, and continuous improvement in post-market surveillance and quality systems.