Quality Engineer: Validation & Process Analytics

RXinsider LTD.; Melrose Park (IL); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits (medical)

Dental coverage

Vision coverage

Job summary

Fresenius Kabi in Melrose Park, IL is seeking a Quality/Validation Specialist to develop and evaluate quality and system standards, investigate validation issues, and verify instrument maintenance. Salary ranges from $80,000 to $110,000. Final pay depends on experience, education, and abilities.

Comprehensive benefits include 401(k), paid vacation, holidays, personal days, EAP, and medical/dental/vision coverage. Strong English communication is essential due to our regulated environment.

Qualifications

• Experience creating and validating procedures for systems and processes.
• Ability to interpret regulatory requirements for validation.
• Strong written and verbal communication in English.

Responsibilities

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

Skills

Quality standards

Statistical analysis

Documentation

Regulatory compliance

Job description

Fresenius Kabi in Melrose Park, IL is seeking a Quality/Validation Specialist to develop and evaluate quality and system standards, investigate validation issues, and verify instrument maintenance. Salary ranges from $80,000 to $110,000. Final pay depends on experience, education, and abilities.

Comprehensive benefits include 401(k), paid vacation, holidays, personal days, EAP, and medical/dental/vision coverage. Strong English communication is essential due to our regulated environment.