Global Quality Process Lead - Complaints & Vigilance

Medline Industries, LP; Northfield (MN); 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 Industries, LP in Northfield, MN seeks an experienced Quality professional to design, integrate, and maintain global complaint management and vigilance processes. You will support regulatory reporting, coding standards, IT system requirements, and data governance across medical devices, pharma, and related products.

The role emphasizes continuous improvement, cross-functional collaboration with Quality, Regulatory Affairs, IT, and Operations, and contributing to CAPA and inspection

Qualifications

• Bachelor’s degree in a scientific, engineering, healthcare, or related technical discipline.
• At least 4 years of experience in medical device or pharmaceutical Quality, complaint management, post-market surveillance, regulatory reporting, investigations, Pharmacovigilance or related regulated processes.

Responsibilities

• Administer, maintain, and support governance of global complaint management and regulatory reporting processes and quality systems.
• Collect, analyze, and report quality data to track performance and compliance.
• Develop and implement improvements to processes and procedures in complaints, investigations, device vigilance, and regulatory reporting.
• Collaborate with cross-functional teams to deploy and integrate quality processes and systems.
• Support hosting regulatory audits and inspections, including inspection-readiness.

Skills

FDA knowledge & QSR

Quality systems

MS Office / MS Visio / MS Project / M-

Data analysis

Education

Bachelor’s degree in science/engineering/healthcare

Tools

SAP

ETQ Reliance

Job description

Medline Industries, LP in Northfield, MN seeks an experienced Quality professional to design, integrate, and maintain global complaint management and vigilance processes. You will support regulatory reporting, coding standards, IT system requirements, and data governance across medical devices, pharma, and related products.

The role emphasizes continuous improvement, cross-functional collaboration with Quality, Regulatory Affairs, IT, and Operations, and contributing to CAPA and inspection