Quality Engineer

301044 Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 70,000 - 110,000; Full time

Job summary

Fresenius Kabi USA, LLC seeks a professional to develop and evaluate manufacturing quality and system standards, investigate validation issues, perform statistical analyses, and verify instrument maintenance. The role includes writing, reviewing, and executing validation documentation to support systems, products, and processes.

Candidate will ensure corrective actions meet reliability standards and that calibration and maintenance activities are properly executed, in alignment with governmental

Qualifications

• Experience developing quality standards and ensuring regulatory compliance.

Responsibilities

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

Skills

Statistical analysis

Quality standards

Validation troubleshooting

Documentation writing

Instrument calibration

Tools

Minitab

Microsoft Excel

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