Quality Engineer: Validation, Analytics & Compliance

301044 Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 70,000 - 110,000; Full time

Job summary

Fresenius Kabi USA, LLC seeks a professional to develop and evaluate manufacturing quality and system standards, investigate validation issues, perform statistical analyses, and verify instrument maintenance. The role includes writing, reviewing, and executing validation documentation to support systems, products, and processes.

Candidate will ensure corrective actions meet reliability standards and that calibration and maintenance activities are properly executed, in alignment with governmental

Qualifications

• Experience developing quality standards and ensuring regulatory compliance.

Responsibilities

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

Skills

Statistical analysis

Quality standards

Validation troubleshooting

Documentation writing

Instrument calibration

Tools

Minitab

Microsoft Excel

Job description

Fresenius Kabi USA, LLC seeks a professional to develop and evaluate manufacturing quality and system standards, investigate validation issues, perform statistical analyses, and verify instrument maintenance. The role includes writing, reviewing, and executing validation documentation to support systems, products, and processes.

Candidate will ensure corrective actions meet reliability standards and that calibration and maintenance activities are properly executed, in alignment with governmental