Global Quality Leader – QMS & Compliance

Regulatory Jobs; Northfield Township (IL); 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 senior quality leader to guide strategic quality initiatives and manage key projects across the quality organization. You will collaborate with cross-functional teams to ensure adherence to regulatory standards and to continually improve the global quality system, while supporting manufacturing efficiency and cost effectiveness.

The role requires deep expertise in ICH Q10, FDA/cGMP guidelines, and inspection readiness, with a proven track record in driving

Qualifications

• Bachelor's degree in mechanical engineering, biomedical engineering, electrical engineering, software engineering, or related science.
• 7+ years in pharmaceutical manufacturing, medical device engineering or quality assurance preferred.
• Willingness to travel up to 30% (domestic and international).

Responsibilities

• Lead quality projects across the quality organization and present results to leadership.
• Drive improvements to the Quality Management System for efficiency and compliance.
• Lead root cause analyses and plan corrective/preventive actions with documentation.
• Evaluate Cost of Quality metrics and propose cost-saving projects.
• Provide process guidance across manufacturing and corporate functions.
• Apply risk management tools (FMEA, fault tree) to mitigate risks.
• Coordinate PQS performance data collection and management review processes.
• Prepare management review reports and dashboards with trends and risks.
• Support inspection readiness and regulatory compliance activities.

Skills

Leadership

Project management

QMS

Regulatory compliance

Risk management

Data analysis

Cross-functional collaboration

Communication

Education

Bachelor's degree in engineering or related science

Job description

Medline Industries, LP is seeking a senior quality leader to guide strategic quality initiatives and manage key projects across the quality organization. You will collaborate with cross-functional teams to ensure adherence to regulatory standards and to continually improve the global quality system, while supporting manufacturing efficiency and cost effectiveness.

The role requires deep expertise in ICH Q10, FDA/cGMP guidelines, and inspection readiness, with a proven track record in driving