MQA Specialist II

Fresenius SE & Co. KGaA; Melrose Park (IL); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Medical/dental/vision coverage

Life insurance

Disability

401K with company contribution

Wellness program

Job summary

Fresenius Kabi in Melrose Park, IL is seeking a quality-focused professional to ensure the quality of manufactured items, maintain infrastructure for timely delivery of quality products, and report deviations. You will define activities to meet quality requirements, audit processes, and collaborate with cross-functional teams to resolve defects while adhering to applicable regulatory standards.

The role offers a comprehensive benefits package and opportunities to contribute to continuous

Qualifications

• Bachelor's degree in engineering or related field required.
• Experience in manufacturing quality assurance or quality control.
• Familiarity with GMP/Regulatory standards is preferred.

Responsibilities

• Define activities, processes, and standards to meet quality requirements for manufactured items.
• Maintain infrastructure to ensure timely delivery of quality products.
• Audit manufacturing processes against internal and regulatory standards.
• Report and troubleshoot deviations and defects in finished goods.

Skills

Quality standards

Process auditing

Regulatory compliance

Education

Bachelor's degree in engineering or related field

Tools

GMP knowledge

Statistical methods

Job description

Job Summary

Applies defined activities, processes, and standards to ensure quality requirements for manufactured items, maintains infrastructure for quality product delivery, audits manufacturing processes, and reports on process deviations and defects.

Responsibilities

• Defining and specifying activities, processes, and standards to fulfill the quality requirements for a manufactured material, component, or product
• Building and maintaining the infrastructure and systems necessary to consistently ensure the timely delivery of quality products
• Auditing, monitoring, and determining the quality of manufacturing processes and/or outputs against defined internal and regulatory standards
• Reporting and troubleshooting manufacturing process deviations and defects in finished goods

Additional Information

We offer an excellent salary and benefits package including

• medical, dental andvision 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 permanentemployment arrangement. All employment is at‑will, meaning both the employeeand 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 applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.