Senior Director, Sustaining Quality & Compliance

Medline; Northfield Township (IL); On-site; USD 177,000 - 266,000; Full time

Benefits offered by this job

Competitive total rewards package

Continuing education & training

Job summary

Medline Industries, LP seeks a seasoned leader to direct Sustaining Quality, ensuring quality and compliance for commercial products and QMS processes. The role translates priorities into functional plans, guiding long-term remediation, lifecycle quality, and systemic improvements.

You will liaise with senior leadership and multiple functions to drive alignment, execution, and audit readiness. The position emphasizes strategy development, governance, risk-based prioritization, and building

Qualifications

• Bachelor's degree in Engineering, Science, Quality, Regulatory Affairs, or a related field.
• Minimum 7 years in medical device/pharma with quality systems, design controls, CAPA, remediation.
• Experience in leadership roles managing cross-functional programs and budgets.

Responsibilities

• Develop and implement strategy for Sustaining Quality aligned with objectives and regulatory commitments.
• Lead cross-functional remediation and product lifecycle quality programs.
• Establish risk-based portfolio management and execution controls for timely mitigation.
• Identify systemic gaps and implement sustainable improvements with process owners.
• Coordinate with senior leadership and key functions to drive alignment and decisions.
• Ensure audit readiness and maintain compliant records.
• Develop performance metrics and executive reporting for remediation and CAPA.
• Lead internal and contract resources to adapt to regulatory and business priorities.

Skills

Quality systems

Design controls

Risk management

CAPA

Remediation

Post-market quality

Data analysis

Excel

Executive communication

Travel

Education

Bachelor's degree in Engineering/Science/Quality/Regulatory Affairs

Tools

Microsoft Excel

Job description

Medline Industries, LP seeks a seasoned leader to direct Sustaining Quality, ensuring quality and compliance for commercial products and QMS processes. The role translates priorities into functional plans, guiding long-term remediation, lifecycle quality, and systemic improvements.

You will liaise with senior leadership and multiple functions to drive alignment, execution, and audit readiness. The position emphasizes strategy development, governance, risk-based prioritization, and building