Global Quality Leader, Medical Devices & CAPA

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

Benefits offered by this job

Medical, dental and vision coverage

401K with company contribution

Wellness program

Life insurance

Disability

Job summary

Fresenius Kabi in the United States seeks a Sr. Principal Engineer, Quality to lead CAPA activities, quality metrics, process improvements, change control, and regulatory compliance across hardware, software, and disposable products.

You will coordinate cross-functional teams, drive issue resolution, and manage investigations and communications with customers. The role also partners with Commercial, R&D, Production Units, and others to advance product quality, reliability, and customer

Qualifications

• Minimum 8+ years in Medical Device (21 CFR 820) and/or Drug (21 CFR 210 & 211) industries, with quality engineering or product development experience.
• Strong knowledge of regulatory standards (ISO13485, FDA Design Control, QSR) and post-market surveillance.
• Proven ability to lead cross-functional teams and coordinate CAPA initiatives.

Responsibilities

• Develop, monitor, and improve quality metrics from local to global levels.
• Coordinate CAPA and product investigations with cross-functional teams.
• Lead change control and support regulatory compliance and audits.
• Provide primary QA contact for customer communications and regulatory inquiries.
• Mentor engineers in test protocols and reporting; influence reliability and safety requirements.

Skills

Quality engineering

CAPA

Regulatory compliance

Cross-functional leadership

Data analysis

Six Sigma

Root cause analysis

Education

B.S. in Science or Engineering

CQE certification

Job description

Fresenius Kabi in the United States seeks a Sr. Principal Engineer, Quality to lead CAPA activities, quality metrics, process improvements, change control, and regulatory compliance across hardware, software, and disposable products.

You will coordinate cross-functional teams, drive issue resolution, and manage investigations and communications with customers. The role also partners with Commercial, R&D, Production Units, and others to advance product quality, reliability, and customer