Quality Engineer: Validation, Analysis & Calibration

Fresenius Kabi; Melrose Park (IL); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi seeks a professional to develop and evaluate manufacturing quality and system standards, investigate validation discrepancies, perform statistical analyses, and verify instrument maintenance in support of compliant operations.

The role also involves writing and reviewing validation procedures and technical reports, ensuring corrective actions meet reliability standards, and supporting calibration activities for instruments across manufacturing processes.

Qualifications

• 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.

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

Statistical analysis

Documentation

Job description

Fresenius Kabi seeks a professional to develop and evaluate manufacturing quality and system standards, investigate validation discrepancies, perform statistical analyses, and verify instrument maintenance in support of compliant operations.

The role also involves writing and reviewing validation procedures and technical reports, ensuring corrective actions meet reliability standards, and supporting calibration activities for instruments across manufacturing processes.