Senior Principal Quality Engineer — CAPA & Global Leader

Fresenius Kabi USA; Lake Zurich (IL); On-site; USD 130,000 - 135,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401(k) with company contribution

Wellness program

Job summary

Fresenius Kabi USA seeks a Sr. Principal Engineer, Quality to drive CAPA, metrics, and regulatory compliance across hardware, software, and disposables.

You will coordinate cross-functional teams, guide investigations, and monitor complaint trends to improve product quality and patient safety. The role requires 8+ years in medical devices/drugs with quality engineering or development experience, leadership experience, and strong knowledge of lean, Six Sigma, and regulatory controls.

Qualifications

• 8+ years of experience in Medical Device and/or Drug industries with quality engineering or product development focus.
• Experience with Post Market Surveillance is a plus.
• Leadership or supervisory experience (minimum 1 year).
• Working knowledge of lean manufacturing, Six Sigma, and project management principles.
• Familiarity with regulatory requirements (FDA 21 CFR 820, ISO 13485, etc.).

Responsibilities

• Develop and monitor quality metrics at local and global levels.
• Lead CAPA, complaint investigations, and SCAR processes.
• Coordinate cross-functional investigations with Engineering, Manufacturing, and other functions.
• Provide regulatory and customer communications support and risk assessments.
• Support New Product Development with reliability and safety considerations.

Skills

Leadership

Problem solving

Cross-functional teamwork

Project management

Quality systems

Education

B.S. in Science or Engineering

Tools

Excel

Job description

Fresenius Kabi USA seeks a Sr. Principal Engineer, Quality to drive CAPA, metrics, and regulatory compliance across hardware, software, and disposables.

You will coordinate cross-functional teams, guide investigations, and monitor complaint trends to improve product quality and patient safety. The role requires 8+ years in medical devices/drugs with quality engineering or development experience, leadership experience, and strong knowledge of lean, Six Sigma, and regulatory controls.