Contamination Control Quality Lead: Strategy & Compliance

Medline Industries; Northfield Township (IL); On-site; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

Medline Industries, LP seeks a senior quality leader to manage and advance quality projects across the organization. You will collaborate with internal and external teams, act as SME for regulatory compliance, and drive continuous improvement of the global quality system, including contingency support for emergencies.

The role emphasizes bridging design with manufacturing, leading QMS improvements, and contributing to contamination control strategies across the pharmaceutical network.

Qualifications

• Bachelor's degree in mechanical, biomedical, electrical, software engineering, or related science.
• Experience leading quality projects in pharma/medical devices.
• Willingness to travel up to 30% (domestic and international).

Responsibilities

• Lead quality initiatives across the organization and collaborate with cross-functional teams.
• Present deliverables to leadership and train affected groups on process changes.
• Identify and drive opportunities to improve the Quality Management System.
• Lead root cause analysis and plan corrective/preventive actions for critical quality concerns.
• Ensure timely actions with evidence documented.
• Evaluate Cost of Quality metrics to identify savings opportunities.
• Propose and implement approved projects for process improvements.
• Provide process guidance across divisions and sites to ensure consistent management.
• Apply risk management tools (FMEA, fault tree) to identify and mitigate risks.
• Contribute to Medline's Global Contamination Control Strategy (CCS).
• Develop practices for environmental monitoring, cleanroom operations, and utilities.
• Provide training and technical leadership at all levels.
• Lead investigations into contamination issues and quality events.
• Serve as SME during audits, inspections, and remediation efforts.

Skills

Quality management

Regulatory compliance

Cross-functional leadership

Root cause analysis

FMEA

Education

Bachelor's degree in engineering or related science

Job description

Medline Industries, LP seeks a senior quality leader to manage and advance quality projects across the organization. You will collaborate with internal and external teams, act as SME for regulatory compliance, and drive continuous improvement of the global quality system, including contingency support for emergencies.

The role emphasizes bridging design with manufacturing, leading QMS improvements, and contributing to contamination control strategies across the pharmaceutical network.