Quality & Validation Engineer

Fresenius Kabi USA; Melrose Park (IL); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401K

Job summary

Fresenius Kabi USA is seeking a professional to develop and evaluate manufacturing quality and system standards, ensuring reliability and regulatory compliance across processes.

The role involves investigating validation discrepancies, performing statistical analyses, and authoring or reviewing validation documentation for systems, products, and processes. It requires meticulous attention to calibration and instrument maintenance to support quality goals.

Responsibilities

• Develop and evaluate quality and system standards to ensure reliability and regulatory compliance.
• Investigate validation discrepancies for systems and performance processes.
• Conduct statistical analyses of testing results and process anomalies.
• Prepare, review, and approve documentation for validation procedures and technical reports.
• Ensure corrective actions meet reliability standards.
• Verify calibration, maintenance and repair of instruments.

Job description

Fresenius Kabi USA is seeking a professional to develop and evaluate manufacturing quality and system standards, ensuring reliability and regulatory compliance across processes.

The role involves investigating validation discrepancies, performing statistical analyses, and authoring or reviewing validation documentation for systems, products, and processes. It requires meticulous attention to calibration and instrument maintenance to support quality goals.