Global Quality Process Architect – Complaints & Vigilance

Medline; Northfield Township (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

Medline seeks aQuality professional to design, implement, and maintain global complaint management, investigations, device vigilance, and regulatory reporting processes across Medline products including medical devices and pharmaceuticals.

With minimal supervision, you will govern data, IT system requirements, and continuous improvement initiatives to harmonize processes, ensure compliance, and support inspections readiness across cross-functional teams.

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, post-market surveillance, regulatory reporting, investigations, Pharmacovigilance, or related processes.
• Knowledge of FDA, QSR, and ISO requirements for post-market surveillance.

Responsibilities

• Administer, maintain, and support governance of global complaint management and regulatory reporting processes and associated quality systems.
• 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 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 across complaint management, investigations, vigilance, regulatory reporting, coding, process effectiveness, and data quality.
• Support development, implementation, testing, and maintenance of complaint/AE IT systems, including user requirements, system fields, workflows, codes, lists of values, and integrations.
• Collaborate with cross-functional teams across Quality, Regulatory Affairs, IT, and other functions to deploy and integrate quality processes and systems.

Skills

Quality systems

Regulatory reporting

Data analysis

Education

Bachelor's degree

Tools

Quality IT systems

Job description

Medline seeks aQuality professional to design, implement, and maintain global complaint management, investigations, device vigilance, and regulatory reporting processes across Medline products including medical devices and pharmaceuticals.

With minimal supervision, you will govern data, IT system requirements, and continuous improvement initiatives to harmonize processes, ensure compliance, and support inspections readiness across cross-functional teams.