Senior Contamination Control & QMS Lead

Medline Industries, Inc.; Northfield (MN); On-site; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a Quality Program Leader to drive quality initiatives across the organization, ensuring regulatory compliance and continuous improvement of the global quality system. You will bridge design and manufacturing, enabling cost-effective production of high-quality products.

The role demands strong cross-functional leadership, expertise in QMS, risk management, and experience with audits and CAPA. Travel up to 30% may be required as part of the scope.

Qualifications

• Bachelor's degree in engineering or related science.
• 7+ years in pharmaceutical manufacturing; medical device quality preferred.
• Willingness to travel up to 30% (domestic and international).
• Experience leading QMS improvements and CAPA.

Responsibilities

• Lead quality initiatives across the organization with cross-functional teams.
• Identify and implement improvements to the Quality Management System for compliance and efficiency.
• Lead root-cause investigations and plan CAPA with timely closure and documentation.
• Evaluate Cost of Quality to identify savings and justify projects.
• Provide process guidance across manufacturing and corporate functions.
• Apply risk management tools (FMEA, risk assessment) to mitigate risks.
• Contribute to Contamination Control Strategy and environmental monitoring improvements.
• Develop best practices for cleanroom operations, gowning, and critical utilities.
• Provide technical training and leadership to personnel at all levels.
• Lead audits, inspections, and remediation efforts as SME.

Skills

Leadership

Project management

Risk management

Quality systems

Cross-functional collaboration

Training/mentorship

Education

Bachelor's degree in engineering or related science

Tools

FMEA

Fault Tree Analysis

CAPA

Statistical methods

Job description

Medline Industries, LP is seeking a Quality Program Leader to drive quality initiatives across the organization, ensuring regulatory compliance and continuous improvement of the global quality system. You will bridge design and manufacturing, enabling cost-effective production of high-quality products.

The role demands strong cross-functional leadership, expertise in QMS, risk management, and experience with audits and CAPA. Travel up to 30% may be required as part of the scope.