Senior Principal Quality Engineer, CAPA & Compliance

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

Job summary

Fresenius Kabi USA in Lake Zurich, IL seeks Sr. Principal Engineer, Quality to lead CAPA, quality metrics, change control, and regulatory compliance across hardware, software, and disposable products.

You will coordinate cross-functional teams, drive timely issue resolution, and communicate with customers. You will develop data-driven quality programs, monitor complaint trends, and support post-market surveillance.

Qualifications

• B.S. degree in Science or Engineering; CQE certification preferred.
• 8+ years in Medical Device and/or Drug industries; quality engineering or product development experience.
• Post Market Surveillance experience is a plus.
• Minimum 1 year of leadership/supervisory responsibility.
• Lean, Six Sigma and Project Management principles experience.
• Familiarity with EN ISO14971, cGMP, QSR, ISO13485, FDA Design Control and risk analyses.

Responsibilities

• Develop, implement, and monitor various quality metrics on local and global levels.
• Identify continuous improvement opportunities and support CAPA/product reviews.
• Drive root cause analysis for complaints and ensure CAPAs are completed.
• Coordinate cross-functional technical investigations with PUs, R&D, and Production.
• Support Post Market Surveillance through investigations and data review.
• Serve as primary QA contact for customer and regulatory inquiries.
• Mentor engineers on test protocols and reports.
• Ensure compliance with regulatory requirements and audits.

Skills

CAPA management

Regulatory compliance

Root cause analysis

Cross-functional teamwork

Change control

Quality metrics

Education

B.S. in Science or Engineering

CQE certification (a plus)

Tools

Excel

Job description

Fresenius Kabi USA in Lake Zurich, IL seeks Sr. Principal Engineer, Quality to lead CAPA, quality metrics, change control, and regulatory compliance across hardware, software, and disposable products.

You will coordinate cross-functional teams, drive timely issue resolution, and communicate with customers. You will develop data-driven quality programs, monitor complaint trends, and support post-market surveillance.