Principal Quality Engineer — QMS & Regulatory Leader

Medline; Northfield Township (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

Medline in the United States seeks a quality leader to guide and manage quality projects across the quality organization. Collaborate with cross-functional teams, serve as a subject matter expert to ensure compliance with applicable regulations and standards; support strategic initiatives to improve the global quality system and provide emergency support when needed.

This role bridges conceptual design and practical manufacturing, enabling cost-effective production of high‑quality products while

Qualifications

• Bachelor’s degree in engineering field.
• 7+ years experience in pharmaceutical manufacturing or medical device quality.
• Willingness to travel up to 30% for business purposes (domestic and international).

Responsibilities

• Lead quality projects across the organization.
• Identify opportunities to improve the QMS and ensure regulatory compliance.
• Lead root cause analysis and CAPA planning.
• Coordinate risk management using methods like FMEA.
• Prepare management review reports and support inspections.

Skills

Leadership abilities

Project management

Risk management

Cross-functional collaboration

Quality systems

Communication

Education

Bachelor's degree in engineering

Job description

Medline in the United States seeks a quality leader to guide and manage quality projects across the quality organization. Collaborate with cross-functional teams, serve as a subject matter expert to ensure compliance with applicable regulations and standards; support strategic initiatives to improve the global quality system and provide emergency support when needed.

This role bridges conceptual design and practical manufacturing, enabling cost-effective production of high‑quality products while