Senior Quality Engineer – Validation & Systems Excellence

Fresenius Kabi USA; Melrose Park (IL); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401(k) with company contribution

Wellness program

Job summary

Fresenius Kabi USA in Melrose Park, IL develops and evaluates manufacturing quality and system standards, investigates validation issues, conducts statistical analyses, and verifies instrument maintenance to support compliant operations.

The role also involves writing and reviewing validation procedures and reports, ensuring corrective actions meet reliability standards, and maintaining calibration and instrument performance in a regulated environment.

Qualifications

• Experience with quality and system standards development.
• Ability to investigate validation discrepancies.
• Proficiency in statistical methods for process analysis.
• Experience writing, reviewing and executing validation procedures and reports.
• Familiarity with calibration, maintenance and repair verification of instruments.

Responsibilities

• Developing and evaluating quality and system standards to ensure reliability and regulatory compliance.
• Investigating/troubleshooting validation discrepancies for systems and processes.
• Conducting statistical analyses of testing results and process anomalies.
• Writing, reviewing, approving and executing documentation for validation procedures and technical reports.
• Ensuring corrective actions meet acceptable reliability standards.
• Verifying calibration, maintenance and repair of instruments.

Skills

Statistical analysis

Validation

Quality systems

Documentation

Calibration

Regulatory compliance

Job description

Fresenius Kabi USA in Melrose Park, IL develops and evaluates manufacturing quality and system standards, investigates validation issues, conducts statistical analyses, and verifies instrument maintenance to support compliant operations.

The role also involves writing and reviewing validation procedures and reports, ensuring corrective actions meet reliability standards, and maintaining calibration and instrument performance in a regulated environment.