Sr Quality Engineer, Critical Systems

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

Benefits offered by this job

Medical, dental & vision coverage

Life insurance

Disability insurance

401(k) with company match

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL is seeking a Validation Professional to develop and evaluate manufacturing quality and system standards, ensuring reliability and regulatory compliance.

The role involves investigating validation discrepancies, performing statistical analyses, and documenting validation procedures and reports while ensuring instrument calibration and maintenance are current. This position offers a competitive salary and benefits.

Responsibilities

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

Job description

Job SummaryDevelops and evaluates manufacturing quality and system standards, investigates validation issues, conducts statistical analysis, and verifies instrument maintenance, potentially assisting in establishing corporate validation policies.ResponsibilitiesThe 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 instrumentsAdditional InformationWe 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.