Director Complaint Process Operation and Investigations

Medline • Mundelein, IL

4d • Hybrid

About The Position

Medline Industries is hiring a Director, Complaint Process Operations & Investigations, based in its Mundelein, Illinois office on a hybrid work model. The role provides strategic and operational leadership for complaint management execution and is accountable for maintaining a compliant, effective, scalable, and standardized complaint quality system across products, divisions, and expanding geographic regions. The Director establishes strategy, governance, performance objectives, and the operating model for complaint intake, investigation, escalation, reportability assessment, and closure.

The Director oversees operational performance, analytics, inspection readiness, process improvement, and timely resolution of audit findings and process-related nonconformances and CAPAs. The role leads and develops quality professionals and collaborates with internal and external partners across Quality, Regulatory Affairs, Medical Affairs, Clinical, Manufacturing, Distribution, Legal, Digital Technology, business leadership, and other functions. The position also supports post-market surveillance strategies and quality system enhancements related to health risk analysis, CAPA, risk management, and field actions.

The position requires at least seven years of experience in quality systems for medical devices, pharmaceuticals, biologics, or other regulated healthcare products, including relevant complaint handling, post-market surveillance, and regulatory reporting experience. It also requires at least four years of progressive people-leadership experience. A bachelor’s degree in a relevant technical discipline or equivalent job-related knowledge is required. Travel may be up to 20% for global business purposes.

Requirements

• Bachelor’s degree in a scientific, engineering, healthcare, or related technical discipline, or equivalent job-related knowledge.
• At least 7 years of experience in medical device, pharmaceutical, biologic, or other regulated healthcare-product quality systems.
• At least 4 years of progressive people-leadership experience leading complex professional teams.
• Relevant experience in complaint handling, post-market surveillance, quality systems, regulatory reporting, and related regulatory requirements.
• Deep working knowledge of applicable FDA, ISO, and international quality and post-market requirements, including FDA, ISO 13485, ISO 14971, and global post-market surveillance requirements.
• Strong understanding of complaint handling, CAPA, risk management, and field actions.
• Demonstrated ability to lead through Senior Managers and Managers and drive organizational performance through others.
• Ability to establish governance, priorities, performance metrics, and escalation pathways.
• Strong analytical, problem-solving, decision-making, and organizational planning capabilities, with sound judgment in risk-based decision-making.
• Ability to communicate effectively with executive management, regulatory authorities, technical teams, and stakeholders.
• Ability to influence senior leaders, achieve cross-functional alignment, and manage multiple complex priorities in a fast-paced, highly regulated environment.
• Excellent written, verbal, and presentation communication skills.
• Proficiency in Microsoft Office applications and data analysis tools.
• Ability to travel up to 20% for global business purposes.

Nice To Haves

• Advanced degree in a relevant scientific, engineering, healthcare, regulatory, or business discipline.
• Certified Manager of Quality/Organization Excellence (ASQ CMQ/QE).
• 15 years of experience leading globally distributed teams in complaint handling, investigations, regulatory reporting, corrections and removals, regulatory authority communications, and regulatory inspections or notified body audits.
• Experience across multiple product types or jurisdictions.
• Working knowledge of risk management, design controls, manufacturing controls, validation, supplier controls, clinical or patient risk assessment, quality system records, and enterprise systems supporting investigation, traceability, and corrective action activities.
• Experience leading regulatory inspections, notified body audits, and health authority interactions related to complaint handling, investigations, and regulatory reporting.

Responsibilities

• Lead teams conducting complaint intake, reviews, investigations, coding, complaint and singular-event risk analysis, escalations, reportability assessments, and closure activities.
• Ensure complaint records and related quality outputs are complete, accurate, consistent, timely, and appropriately documented.
• Ensure compliance with applicable regulatory requirements and internal quality system procedures.
• Establish departmental objectives and operational priorities, using analytics and monitoring to identify emerging risks, 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, compliant solutions.
• Maintain inspection readiness and represent complaint operations during internal and external audits, regulatory inspections, and other compliance assessments.
• Support complaint process improvements focused on compliance, investigation quality, customer experience, efficiency, simplification, and standardization.
• Lead managers, supervisors, and professional staff; manage staffing, performance, coaching, succession planning, and resource allocation.
• Build technical expertise through mentoring and development, and promote a culture of quality, compliance, accountability, and continuous improvement.
• Translate divisional and functional strategies into operational surveillance plans and support post-market surveillance strategies for product portfolios and complaint operations.
• Partner with internal and external stakeholders, including Regulatory Affairs, Medical Affairs, R&D, Manufacturing, Supply Chain, Legal, Commercial, Quality functions, regional teams, and vendors.
• 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.

Benefits

• Competitive total rewards package.
• Continuing education and training.
• Health insurance.
• Life and disability insurance.
• 401(k) contributions.
• Paid time off.
• Bonus and/or incentive eligibility.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp access for employees working less than 30 hours per week.

What This Job Offers

• Job Type: Full-time
• Career Level: Director