Sr Quality Engineer, Critical Systems

Fresenius Kabi USA; Melrose Park (IL); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401(k) with company contribution

Wellness program

Job summary

Fresenius Kabi USA in Melrose Park, IL develops and evaluates manufacturing quality and system standards, investigates validation issues, conducts statistical analyses, and verifies instrument maintenance to support compliant operations.

The role also involves writing and reviewing validation procedures and reports, ensuring corrective actions meet reliability standards, and maintaining calibration and instrument performance in a regulated environment.

Qualifications

• Experience with quality and system standards development.
• Ability to investigate validation discrepancies.
• Proficiency in statistical methods for process analysis.
• Experience writing, reviewing and executing validation procedures and reports.
• Familiarity with calibration, maintenance and repair verification of instruments.

Responsibilities

• Developing and evaluating quality and system standards to ensure reliability and regulatory compliance.
• Investigating/troubleshooting validation discrepancies for systems and processes.
• Conducting statistical analyses of testing results and process anomalies.
• Writing, reviewing, approving and executing documentation for validation procedures and technical reports.
• Ensuring corrective actions meet acceptable reliability standards.
• Verifying calibration, maintenance and repair of instruments.

Skills

Statistical analysis

Validation

Quality systems

Documentation

Calibration

Regulatory compliance

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.