Quality Validation Engineer – Data-Driven Compliance

Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life Insurance

Disability Insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA, LLC in Melrose Park, IL is seeking a role focused on developing and evaluating manufacturing quality and system standards to ensure reliability and regulatory compliance. You will investigate validation discrepancies, perform statistical analyses, and contribute to documentation for validation procedures and reports.

The position emphasizes maintaining instrument calibration and maintenance, with the potential to help establish corporate validation policies, while ensuring

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

Job description

Fresenius Kabi USA, LLC in Melrose Park, IL is seeking a role focused on developing and evaluating manufacturing quality and system standards to ensure reliability and regulatory compliance. You will investigate validation discrepancies, perform statistical analyses, and contribute to documentation for validation procedures and reports.

The position emphasizes maintaining instrument calibration and maintenance, with the potential to help establish corporate validation policies, while ensuring