Sr Quality Engineer, Critical Systems

301044 Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA, LLC is seeking a professional to develop and evaluate quality and system standards for manufacturing, ensuring reliability and compliance with regulatory requirements. The role includes investigating validation discrepancies and conducting statistical analyses of testing results.

You will also write and review validation documentation, ensure corrective actions meet reliability standards, and verify instrument calibration, maintenance, and repair.

Qualifications

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

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 standards

Validation

Statistical analysis

Documentation

Regulatory compliance

Calibration

Troubleshooting

GxP

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

• 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, and wellness 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.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.

Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr