Senior Quality Engineer – Contamination Control Strategy

Medline; Northfield Township (IL); On-site; USD 110,000 - 160,000; Full time

Job summary

Medline is seeking a seasoned quality professional to lead and manage quality projects across the quality organization. You will collaborate with cross-functional teams and serve as a subject matter expert to ensure compliance with applicable regulations and standards.

You will support strategic initiatives toward a global quality system, provide training and technical leadership, and bridge conceptual design with practical manufacturing for cost-effective, high‑quality production.

Qualifications

• Bachelor's degree in engineering or related science.
• 7+ years in pharmaceutical manufacturing; medical device QA experience preferred.
• Willing to travel up to 30% for business purposes (domestic and international).

Responsibilities

• Lead quality improvement projects across the quality organization with cross-functional teams.
• Drive improvements to the Quality Management System for efficiency and compliance.
• Lead root cause analyses and coordinate corrective/preventive actions with proper documentation.
• Evaluate Cost of Quality metrics and propose savings opportunities.
• Provide process guidance across manufacturing and corporate functions to ensure standardized practices.
• Lead investigations on contamination control issues and product quality events.

Skills

Quality management

Regulatory compliance

Cross-functional collaboration

Root cause analysis

Risk management

Education

Bachelor's degree in mechanical engineering

Biomedical engineering

Electrical engineering

Software engineering

Related science

Job description

Medline is seeking a seasoned quality professional to lead and manage quality projects across the quality organization. You will collaborate with cross-functional teams and serve as a subject matter expert to ensure compliance with applicable regulations and standards.

You will support strategic initiatives toward a global quality system, provide training and technical leadership, and bridge conceptual design with practical manufacturing for cost-effective, high‑quality production.