Global Quality Process Lead - Complaints & Vigilance

Medline; Northfield Township (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 an experienced Quality Process Design professional focused on global complaint management, investigations, device vigilance, and regulatory reporting. You will ensure integrity of complaint processes, coding standards, and data systems across products including medical devices and pharmaceuticals while supporting governance and continuous improvement.

The role involves cross-functional collaboration with Quality, Regulatory Affairs, IT, and product divisions,

Qualifications

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

Responsibilities

• Administer, maintain, and support governance of global complaint management and regulatory reporting processes and associated quality systems, including procedures, work instructions, regulatory reporting frameworks, vigilance assessment, coding standards, and process requirements.
• Collect, analyze, and report quality data to track performance and compliance. Develop and implement improvements to processes and procedures, including complaint handling, investigations, device vigilance, regulatory reporting, coding, and associated process and system controls.
• Identify and advise on opportunities to improve processes and systems that support global process harmonization, compliance, and effective complaint and vigilance operations.
• Track performance and compliance of key quality metrics/indicators, including operational and management review metrics supporting complaint management, investigations, vigilance, regulatory reporting, coding, process effectiveness, and system/data quality.
• Reviews and determine the application of various system compliance regulations. Ensure compliance to global regulatory requirements with internal procedures. Identify risk and compliance opportunities.
• Support development, implementation, testing, and maintenance of complaint/AE IT system, including user requirements, system fields, workflows, codes, lists of values, integrations, and business rules.
• Collaborate with cross-functional teams across Quality, Regulatory Affairs, Medical/Clinical, Product Divisions, Operations, IT, and other applicable business functions, to deploy and integrate quality processes and systems. Consult and provide guidance to business partners.
• Support hosting regulatory audits and inspections, including inspection-readiness support and CAPA.
• Provide project guidance, training, and coaching. Support implementation and integration of global processes, change management, and ongoing governance, including new or revised regulatory requirements, acquisitions, IT complaint/AE system implementation, system enhancements, integrations, and event-driven process changes.
• Serve as a Center of Excellence resource for post-market processes, systems, standards, best practices, process standardization, global harmonization, training support, and continuous improvement.

Skills

FDA & QSR knowledge

ISO knowledge

Quality systems

Procedures & documentation

MS Office suite

MS Visio

MS Project

Minitab

Travel up to 10%

Education

Bachelor’s degree in a scientific, engineering, healthcare, or related technical discipline

Tools

SAP

ETQ Reliance

Job description

Medline Industries, LP is seeking an experienced Quality Process Design professional focused on global complaint management, investigations, device vigilance, and regulatory reporting. You will ensure integrity of complaint processes, coding standards, and data systems across products including medical devices and pharmaceuticals while supporting governance and continuous improvement.

The role involves cross-functional collaboration with Quality, Regulatory Affairs, IT, and product divisions,