Director, Complaint Process & Investigations (Hybrid)

Medline; Mundelein (IL); Hybrid; USD 180,000 - 230,000; Full time

Job summary

Medline Industries is seeking a Director of Complaint Process Operations & Investigations to lead the global complaint management effort from Mundelein, IL, in a hybrid setting. The role drives a compliant, scalable quality system across products and regions, establishing strategy, governance, and operating models for intake, investigation, escalation, reportability, and closure.

The position leads a team of quality professionals and collaborates with Quality, Regulatory Affairs, Medical

Qualifications

• 7+ years in medical device/pharma quality systems.
• 4+ years of progressive people leadership experience.
• Deep knowledge of FDA, ISO quality standards; strong analytical and risk-based decision-making.

Responsibilities

• Lead complaints intake, investigations, escalations, reportability assessments, and closure activities.
• Ensure complaint records and related outputs are complete, accurate, consistent, timely, and well documented.
• Ensure compliance with applicable regulatory requirements and internal quality procedures.
• Establish objectives and use analytics to identify risks, trends, and improvement opportunities.
• Monitor KPIs and quality metrics, capacity indicators, timeliness, investigation quality, and process effectiveness.
• Escalate patient, product, regulatory, and business risks to leadership as needed.
• Collaborate with cross-functional partners to implement compliant solutions.
• Maintain inspection readiness and support audits and inspections.

Skills

Leadership

Quality systems

FDA knowledge

ISO 13485

CAPA

Post-market surveillance

Risk management

Regulatory reporting

Data analytics

Executive communication

Education

Bachelor's degree in science/engineering/healthcare

Job description

Medline Industries is seeking a Director of Complaint Process Operations & Investigations to lead the global complaint management effort from Mundelein, IL, in a hybrid setting. The role drives a compliant, scalable quality system across products and regions, establishing strategy, governance, and operating models for intake, investigation, escalation, reportability, and closure.

The position leads a team of quality professionals and collaborates with Quality, Regulatory Affairs, Medical