Director Complaint Process Operation and Investigations

Medline Industries, LP•Mundelein, IL

6d•$177,000 - $266,000•Hybrid

About The Position

Medline Industries is hiring a Director, Complaint Process Operations & Investigations, based in its Mundelein, Illinois office under 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 position oversees operational performance, analytics, inspection readiness, process improvements, and timely resolution of audit findings and process-related nonconformances and corrective and preventive actions. It leads and develops quality professionals and collaborates with internal and external partners across Quality, Regulatory Affairs, Medical Affairs, Clinical, Manufacturing, Distribution, Legal, Digital Technology, and business leadership. The role also supports post-market surveillance strategies and quality system enhancements involving 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 complaint handling, post-market surveillance, and regulatory reporting. It also requires at least four years of progressive people leadership experience. Travel for business purposes may be up to 20% globally.

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.
Knowledge of 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, organizational planning, and risk-based judgment capabilities.
Excellent written, verbal, and presentation communication skills, including the ability to communicate effectively with executive management, regulatory authorities, technical teams, and stakeholders.
Ability to influence senior leaders and achieve cross-functional alignment.
Ability to manage multiple complex priorities and deliver results in a fast-paced, highly regulated environment.
Proficiency in Microsoft Office applications and data analysis tools.
Ability to travel globally for business purposes up to 20%.

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 removal, 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.
Strong strategic thinking and ability to translate business and quality objectives into functional plans and execution.
Ability to lead regulatory inspections, notified body audits, and health authority interactions related to complaint handling, investigations, and regulatory reporting.
Ability to develop talent, build organizational capability, and promote patient safety, accountability, and continuous improvement.

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 supported by appropriate documentation.
Ensure compliance with applicable regulatory requirements and internal quality system procedures.
Establish departmental objectives and operational priorities, and use 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, 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 organizational technical expertise through mentoring and development activities, and promote 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 operations.
Partner with Regulatory Affairs, Medical Affairs, R&D, Manufacturing, Supply Chain, Legal, Commercial, Quality functions, regional teams, vendors, and other stakeholders.
Collaborate with product subject matter experts to ensure appropriate event assessment and escalation.
Contribute to quality system enhancements involving Health Risk Analysis, CAPA, risk management, and field actions.

Benefits

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