Sr Dir, CAPA and Deviations

Medline Industries, LP•Northfield, IL

11d•$203,000 - $305,000

About The Position

Leads the global strategy, governance, and continuous improvement of CAPA, Nonconformance, and Deviation processes. Serves as the Global Process Owner responsible for establishing enterprise standards, driving consistent execution across sites and business units, and ensuring effective investigation, risk mitigation, and regulatory compliance.

Requirements

Bachelor’s degree
Minimum of 8 years of experience in the functional area, including 5 years of management experience.
Expertise in CAPA, Nonconformance, Deviation, root cause analysis, and quality systems governance.
Experience leading enterprise-wide quality system processes and cross-functional initiatives in a global, multi-site environment.
Strong knowledge of applicable regulatory requirements and industry standards.
Proven leadership, influencing, analytical, and communication skills.
Ability to travel as required.

Responsibilities

Build and maintain the CAPA infrastructure, including process design, workflows, tools, and templates that support effective root cause investigation, action planning, and effectiveness verification
Own reporting and metrics across all three processes, providing visibility into volume, aging, closure performance, and recurrence, and surfacing systemic trends for escalation into management review
Define and lead the CAPA Review Board, setting its charter, membership, escalation criteria, and decision rights, and establish equivalent governance for Nonconformance and Deviation to ensure consistent disposition and escalation
Build organizational capability in investigation and CAPA execution, developing and delivering training and coaching so teams can identify true root cause and implement durable corrective actions