Senior Global Quality & Complaint Process Lead

Medline Industries, Inc.; 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, Inc. is seeking a senior Quality professional to lead global complaint management and regulatory reporting processes across devices, pharmaceuticals, biologics, cosmetics, and related products.

You will design, implement, and maintain governance, data standards, and process controls to assure compliance and data integrity. The role collaborates with Regulatory, IT, and Operations to harmonize processes, support audits, CAPA, and continuous improvement, with up to 10% travel.

Qualifications

• 4+ years in medical device/pharma quality, complaint management, or regulatory processes.
• Knowledge of FDA, QSR, ISO requirements in post-market surveillance.
• Experience with quality systems development and controlled documentation.

Responsibilities

• Administer, maintain, and support governance of global complaint management and regulatory reporting processes and quality systems.
• Collect, analyze, and report quality data; implement improvements to processes and procedures.
• Identify opportunities to improve processes and systems for global harmonization and compliance.
• Track performance of key quality metrics and regulatory reporting activities.
• Support development, testing, and maintenance of IT systems for complaint/vigilance.

Skills

FDA knowledge

QSR knowledge

ISO knowledge

Quality systems

Process governance

Data standards

Education

Bachelor’s degree in a scientific/engineering/healthcare field

Tools

SAP

ETQ Reliance

MS Office

MS Visio

MS Project

Minitab

Job description

Medline Industries, Inc. is seeking a senior Quality professional to lead global complaint management and regulatory reporting processes across devices, pharmaceuticals, biologics, cosmetics, and related products.

You will design, implement, and maintain governance, data standards, and process controls to assure compliance and data integrity. The role collaborates with Regulatory, IT, and Operations to harmonize processes, support audits, CAPA, and continuous improvement, with up to 10% travel.