Quality Engineer

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401K

Job summary

Fresenius Kabi USA is seeking a professional to develop and evaluate manufacturing quality and system standards, ensuring reliability and regulatory compliance across processes.

The role involves investigating validation discrepancies, performing statistical analyses, and authoring or reviewing validation documentation for systems, products, and processes. It requires meticulous attention to calibration and instrument maintenance to support quality goals.

Responsibilities

• Develop and evaluate quality and system standards to ensure reliability and regulatory compliance.
• Investigate validation discrepancies for systems and performance processes.
• Conduct statistical analyses of testing results and process anomalies.
• Prepare, review, and approve documentation for validation procedures and technical reports.
• Ensure corrective actions meet reliability standards.
• Verify calibration, maintenance and repair of instruments.

Job description

Job Summary

Develops and evaluates manufacturing quality and system standards, investigates validation issues, conducts statistical analysis, and verifies instrument maintenance, potentially assisting in establishing corporate validation policies.

Responsibilities

The Professional performs some or all of the following accountabilities as assigned:

• 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

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.