Quality Engineer — Validation & Process Analytics

Fresenius Kabi; Melrose Park (FL); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401K with company contributions

Wellness program

Job summary

Fresenius Kabi is seeking a specialist to develop and evaluate manufacturing quality and system standards, ensuring regulatory compliance and reliable performance of processes and equipment.

The role involves investigating validation discrepancies, performing statistical analyses, and writing or reviewing validation documentation and technical reports related to systems, products, and processes. Calibration verification and instrument maintenance are key duties.

Qualifications

• Experience validating systems and processes.
• Ability to analyze testing results statistically.
• Familiarity with calibration and instrument maintenance.

Responsibilities

• Develop and evaluate quality and system standards for reliability and regulatory compliance.
• Investigate validation discrepancies for systems and performance processes.
• Conduct statistical analyses of tests and process anomalies.
• Document validation procedures and technical reports.
• Ensure corrective actions meet reliability standards.
• Verify calibration, maintenance and repair of instruments.

Skills

Statistical analysis

Quality systems

Regulatory compliance

Documentation

Troubleshooting

Job description

Fresenius Kabi is seeking a specialist to develop and evaluate manufacturing quality and system standards, ensuring regulatory compliance and reliable performance of processes and equipment.

The role involves investigating validation discrepancies, performing statistical analyses, and writing or reviewing validation documentation and technical reports related to systems, products, and processes. Calibration verification and instrument maintenance are key duties.