Quality Engineer

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

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

The 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 instruments

Salary range between $80,000 - $110,000

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
• The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

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 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.