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Quality Control Jobs in Chicago, IL

Quality Engineer

Katalyst Healthcares & Life Sciences
  • chicago, IL
  • Instant Apply
30+ days ago

Job Description

Job Summary:
  • Quality Engineer / Quality Compliance Engineer with experience supporting remediation efforts and maintaining quality standards within regulated medical device, pharmaceutical, OTC drug, and cosmetic environments.
  • Responsible for supporting Quality Management Systems (QMS), Design Controls, CAPA, Risk Management, supplier quality activities, process validation, and regulatory compliance while ensuring adherence to FDA and ISO quality standards.

Roles & Responsibilities:
  • Provide quality engineering support for Product Development, QMS, Design Controls, Design History Files (DHF), CAPA, Risk Management, and CE Technical File activities.
  • Support remediation projects and ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable domestic/international regulations.
  • Collaborate with supplier representatives to resolve quality issues, implement CAPA/SCAR activities, and support supplier qualification and vendor management programs.
  • Lead investigations related to product/process non-conformances, deviations, and out-of-specification (OOS) results, performing root cause analysis and corrective actions.
  • Review design and quality documentation to ensure compliance with regulatory requirements and company standards.
  • Support process control, process validation, testing, inspection, and continuous improvement activities to enhance product quality and manufacturing efficiency.
  • Apply Statistical Process Control (SPC) methods and statistical analysis techniques to evaluate process performance and identify process variation trends.
  • Design and execute product testing, data analysis, and failure investigations to minimize defects and improve product reliability.
  • Coordinate product testing activities with internal teams and external laboratories.
  • Develop and maintain Device Master Records (DMR), product specifications, validation documentation, and technical files in compliance with regulatory requirements.
  • Support preparation of regulatory submissions including 510(k) documentation, letters to file, and other quality compliance documentation.
  • Collaborate with cross-functional teams including Manufacturing, Regulatory Affairs, Quality Systems, and Suppliers to ensure quality-compliant project execution.

Education & Experience:
  • Bachelor's degree in engineering, Science, Mathematics, or a related technical field.
  • 2 5 years of Quality Engineering experience in Medical Device and/or pharmaceutical industries.
  • Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and regulated quality system requirements.
  • Hands-on experience with Device History Files (DHF), CAPA, Risk Management, supplier quality, and compliance activities.
  • Experience supporting investigations, process validation, remediation projects, and quality system compliance in regulated environments.
  • Knowledge of Design Controls, SPC, statistical analysis, process improvement methodologies, and validation activities.
  • Strong analytical, problem-solving, communication, and documentation skills.

Numbers & Facts

Locationchicago, IL

Skills

  • Analysis Skillsunmatched
  • Biotech and Pharmaceuticalunmatched
  • Code of Federal Regulationsunmatched
  • Continuous Improvementunmatched
  • Corrective Actionunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cross-Functionalunmatched
  • Data Analysisunmatched
  • Documentationunmatched
  • Engineeringunmatched
  • FDA (Food and Drug Administration)unmatched
  • ISO (International Organization for Standardization)unmatched
  • Laboratoryunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Manufacturing Requirementsunmatched
  • Mathematicsunmatched
  • Medical Equipmentunmatched
  • Problem Solving Skillsunmatched
  • Process Control Engineeringunmatched
  • Process Developmentunmatched
  • Process Improvementunmatched
  • Process Validationunmatched
  • Product Designunmatched
  • Product Developmentunmatched
  • Product Supportunmatched
  • Product Testingunmatched
  • Project Executionunmatched
  • Quality Engineeringunmatched
  • Quality Managementunmatched
  • Quality Metricsunmatched
  • Quality System Requirements (QSR)unmatched
  • Record Keepingunmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Regulatory Requirementsunmatched
  • Regulatory Submissionsunmatched
  • Reliability Engineeringunmatched
  • Risk Managementunmatched
  • Root Cause Analysisunmatched
  • Statistical Process Controlunmatched
  • Statisticsunmatched
  • Technical Writingunmatched
  • Test Dataunmatched
  • Trend Analysisunmatched
  • Validation Documentationunmatched
  • Validation Testingunmatched
  • Vendor/Supplier Managementunmatched
  • Vendor/Supplier Quality Managementunmatched

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