Senior Quality Engineer - Critical Systems Validation

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

Job summary

Fresenius Kabi USA, LLC seeks a Validation/Quality Specialist to develop and evaluate manufacturing quality and system standards, investigate validation issues, perform statistical analyses, and verify instrument maintenance across processes and systems.

The role includes writing and approving validation documentation and ensuring corrective actions meet reliability standards in line with regulatory requirements.

Qualifications

• Experience with manufacturing quality systems and validation practices.
• Strong ability to analyze data and interpret statistical results.
• Proficient at writing, reviewing, and approving validation documentation.

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 systems knowledge

Statistical analysis

Documentation writing

Education

Bachelor's degree in Engineering or related field

Tools

Validation software

Job description

Fresenius Kabi USA, LLC seeks a Validation/Quality Specialist to develop and evaluate manufacturing quality and system standards, investigate validation issues, perform statistical analyses, and verify instrument maintenance across processes and systems.

The role includes writing and approving validation documentation and ensuring corrective actions meet reliability standards in line with regulatory requirements.