Sr Quality Engineer, Critical Systems

Fresenius Kabi USA, LLC; Melrose Park (IL); On-site; USD 70,000 - 90,000; Full time

Job summary

Fresenius Kabi USA, LLC seeks a Validation/Quality Specialist to develop and evaluate manufacturing quality and system standards, investigate validation issues, perform statistical analyses, and verify instrument maintenance across processes and systems.

The role includes writing and approving validation documentation and ensuring corrective actions meet reliability standards in line with regulatory requirements.

Qualifications

• Experience with manufacturing quality systems and validation practices.
• Strong ability to analyze data and interpret statistical results.
• Proficient at writing, reviewing, and approving validation documentation.

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 systems knowledge

Statistical analysis

Documentation writing

Education

Bachelor's degree in Engineering or related field

Tools

Validation software

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, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, 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.