Global Quality Process Lead - Complaints & Vigilance

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

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries is seeking a Quality Systems professional to design, integrate, implement, and maintain global complaint management, investigations, device vigilance, and regulatory reporting processes. You will support governance, data standards, and IT system requirements to ensure compliant and standardized practices across the organization.

The role involves collaborating with Quality, Regulatory Affairs, IT, and product divisions to deploy harmonized processes, support audits, and drive

Qualifications

• Bachelor’s degree in a scientific, engineering, healthcare, or related technical discipline or equivalent
• 4+ years of experience in medical device or pharmaceutical Quality, complaint management, or related regulated processes
• Knowledge of FDA, QSR, ISO requirements and post-market surveillance practices
• Ability to develop and maintain procedures, work instructions, processes, and data standards
• Experience with quality systems development and implementation, and cross-functional collaboration

Responsibilities

• Administer and support governance of global complaint management and regulatory reporting processes
• Collect, analyze, and report quality data to track performance and compliance
• Develop and implement improvements to processes and procedures
• Identify risk and compliance opportunities and support remediation
• Collaborate with cross-functional teams to deploy quality processes and systems
• Support audits, inspections, and CAPA activities
• Provide training and coaching on global processes and IT systems

Skills

FDA knowledge

QSR knowledge

ISO knowledge

Process governance

Education

Bachelor's degree

Tools

MS Office

MS Visio

MS Project

Minitab

SAP

ETQ Reliance

Job description

Medline Industries is seeking a Quality Systems professional to design, integrate, implement, and maintain global complaint management, investigations, device vigilance, and regulatory reporting processes. You will support governance, data standards, and IT system requirements to ensure compliant and standardized practices across the organization.

The role involves collaborating with Quality, Regulatory Affairs, IT, and product divisions to deploy harmonized processes, support audits, and drive