Director Complaint Process Operation and Investigations

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

Job Summary

Medline Industries has an immediate opening for a Director Complaint Process Operations & Investigations. This role will be based out of our Mundelein, IL office and will work a hybrid model. The Director, Complaint Process Operation and Investigations provides strategic and operational leadership for the complaint management process execution. This position is accountable for maintaining a compliant, effective, scalable, and standardized complaint quality system across products, division, expanding to geographic regions. The Director establishes strategy, governance, performance objectives, and operating model for complaint intake, investigation, escalation, reportability assessment, and closure. The role oversees operational performance, analytics, inspection readiness, process improvements, and the timely resolution of audit findings and process-related NCRs and CAPAs. This position leads and develops a team of quality professionals and collaborates with Quality, Regulatory Affairs, Medical Affairs, Clinical, Manufacturing, Distribution, Legal, Digital Technology, and business leadership.

Job Description

MAJOR RESPONSIBILITIES

• Lead teams conducting complaints intake, reviews, investigations, coding, complaint/singular event risk analysis, escalations, reportability assessments, and closure activities.
• Ensure complaint records and related quality outputs are complete, accurate, consistent, timely, and supported by appropriate documentation.
• Ensure compliance with applicable regulatory requirements and internal quality system procedures.
• Establish departmental objectives and operational priorities and use operational analytics and monitoring to identify emerging risks, negative performance trends, compliance concerns, and improvement opportunities.
• Monitor operational KPIs and KQIs, quality metrics, capacity indicators, timeliness, investigation quality, and process effectiveness.
• Ensure timely escalation of patient, product, regulatory, and business risks to Medical, Regulatory Affairs, Quality, and executive leadership.
• Collaborate with cross-functional partners to resolve compliance issues and establish practical, sustainable, and compliant solutions.
• Maintain inspection readiness and represent complaint operations during internal audits, external audits, regulatory inspections, and other compliance assessments.
• Support complaint process improvements focused on compliance, investigation quality, customer experience, efficiency, simplification, and standardization.
• Provide leadership to managers, supervisors, and professional staff.
• Manage staffing, performance management, coaching, succession planning, and resource allocation.
• Build technical expertise within the organization through mentoring and development activities.
• Promote a culture of quality, compliance, accountability, and continuous improvement.
• Translate divisional and functional strategies into operational surveillance plans.
• Support development of post-market surveillance strategies for product portfolios and complaint process operation.
• Partner with Regulatory Affairs, Medical Affairs, R&D, Manufacturing, Supply Chain, Legal, Commercial, Quality functions, regional teams, vendors, and other internal and external stakeholders.
• Collaborate with product subject matter experts to ensure appropriate event assessment and escalation.
• Contribute to quality system enhancements affecting Health Risk Analysis, CAPA, risk management, and field actions.

MINIMUM JOB REQUIREMENTS

Education

A bachelor's degree in a scientific, engineering, healthcare, or related technical discipline, or equivalent job-related knowledge.

Work Experience

The position requires at least 7 years of experience in medical device, pharmaceutical, biologic, or other regulated healthcare-product quality systems and demonstrated 4+ years of progressive people leadership experience leading complex professional teams. Relevant experience should include complaint handling, post-market surveillance, quality systems, regulatory reporting, and related regulatory requirements. The successful candidate must demonstrate deep working knowledge of applicable FDA, ISO, and international quality and post-market requirements; strong analytical, problem-solving, decision-making, and organizational planning capabilities; sound judgment in risk-based decision-making; ability to communicate effectively with executive management, regulatory authorities, technical teams, and stakeholders; and ability to manage multiple complex priorities and deliver results in a fast-paced, highly regulated environment.

Knowledge / Skills / Abilities

• Demonstrated ability to lead through Senior Managers and Managers and drive organizational performance through others.
• Knowledge of FDA, ISO 13485, ISO 14971, and global post-market surveillance requirements.
• Strong understanding of complaint handling, CAPA, risk management, and field actions.
• Ability to establish governance, priorities, performance metrics,