Quality Engineer

Katalyst CRO; Chicago (IL); On-site; USD 70,000 - 90,000; Full time

Job summary

Katalyst CRO seeks a Quality Engineer based in Chicago, IL, to establish quality standards across medical devices, OTC drugs, and cosmetics. This role involves evaluating production processes, managing suppliers, investigating non-conformities, and ensuring compliance with regulations. Qualified candidates should have at least 2 years of experience in Quality or Engineering, strong analytical skills, and proficiency in MS Office Suite. Experience in the medical device industry is preferred, and the position may offer hybrid work options.

Qualifications

• Proven experience in quality engineering and compliance.
• Ability to manage multiple projects and priorities effectively.
• Familiarity with regulatory requirements like 21 CFR 820 and ISO 13485.

Responsibilities

• Establish and maintain quality standards across products.
• Collaborate with suppliers to resolve quality issues.
• Evaluate production processes and recommend improvements.
• Conduct investigations on non-conformances and product testing.
• Create and manage product documentation related to quality control.

Skills

Problem-solving

Analytical skills

Knowledge of quality standards

Microsoft Excel proficiency

Education

Minimum 2 years of experience in Quality or Engineering

At least 2 years of industry experience in Medical Devices or Pharmaceuticals

Tools

MS Office Suite

Job description

Job Summary

The Quality Engineer provides cross‑divisional support for remediation efforts and is responsible for independently establishing and maintaining quality standards across a portfolio that includes medical devices, commodities, OTC drugs, and cosmetic products. The role involves evaluating production processes, recommending improvements, managing suppliers, and ensuring compliance with regulatory requirements through proper documentation and quality systems.

• Provide quality expertise in Product Development, Design Control, Design History Files (DHF), CAPA, Risk Management, and CE Technical Files.
• Collaborate with suppliers to resolve quality issues, implement corrective actions (CAPA, SCAR), and lead supplier qualification activities.
• Investigate product and process non‑conformances, out‑of‑specification results, and implement corrective and preventive actions.
• Ensure compliance with domestic and international regulations; review design and quality documentation for adherence to requirements.
• Develop and implement methods for process control, validation, testing, inspection, and continuous improvement.
• Design experiments to identify process variation and apply Statistical Process Control (SPC) techniques.
• Perform product testing and data analysis to monitor quality levels, identify trends, and reduce defects.
• Coordinate testing with internal and external laboratories.
• Create and maintain product documentation such as Device Master Records (DMR) and support regulatory submissions (e.g., 510K, letters to file).

Education & Experience

• Minimum 2 years of experience in Quality or Engineering.
• At least 2 years of industry experience in Medical Devices, Pharmaceuticals (Drugs), or related fields preferred.
• Working knowledge of quality standards and regulations such as 21 CFR 820 and ISO 13485.
• Strong problem‑solving and analytical skills using systematic and mathematical approaches.
• Ability to work independently, manage multiple priorities, and elevate issues when needed.
• Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook).
• Intermediate skills in Microsoft Excel (e.g., formulas, tables, conditional formatting, charting).