Senior Quality Engineer - Critical Systems Validation

301044 Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA, LLC is seeking a professional to develop and evaluate quality and system standards for manufacturing, ensuring reliability and compliance with regulatory requirements. The role includes investigating validation discrepancies and conducting statistical analyses of testing results.

You will also write and review validation documentation, ensure corrective actions meet reliability standards, and verify instrument calibration, maintenance, and repair.

Qualifications

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

Responsibilities

• Developing and evaluating quality and system standards to ensure reliability and compliance with company standards and governmental regulatory requirements.
• Investigating/troubleshooting validation discrepancies for systems and/or performance processes.
• Conducting statistical analyses of testing results and process anomalies.
• Writing, reviewing, approving and/or executing documentation for new and current validation procedures and technical reports related to systems, products and/or processes.
• Ensuring corrective measures meet acceptable reliability standards.
• Verifying calibration, maintenance and repair of instruments.

Skills

Quality standards

Validation

Statistical analysis

Documentation

Regulatory compliance

Calibration

Troubleshooting

GxP

Job description

Fresenius Kabi USA, LLC is seeking a professional to develop and evaluate quality and system standards for manufacturing, ensuring reliability and compliance with regulatory requirements. The role includes investigating validation discrepancies and conducting statistical analyses of testing results.

You will also write and review validation documentation, ensure corrective actions meet reliability standards, and verify instrument calibration, maintenance, and repair.