Quality Engineer

Job Title: Quality Engineer

Location: Chicago, IL (Onsite)

Experience: 3–5 Years

Employment: Contract

Job Description

We are seeking a Quality Engineer with 3–5 years of experience in a regulated manufacturing environment. The ideal candidate will have hands-on experience with quality systems, process improvement, root cause investigations, and validation activities while ensuring compliance with industry and regulatory standards.

Key Responsibilities

• Support Quality Assurance and Quality Engineering activities in manufacturing operations.
• Investigate non-conformances, deviations, customer complaints, and implement effective CAPA.
• Perform root cause analysis using quality tools such as 5 Why, Fishbone, and FMEA.
• Review and approve quality documentation, SOPs, protocols, and reports.
• Support equipment, process, and product validation activities (IQ/OQ/PQ).
• Participate in internal and external audits and ensure compliance with quality standards.
• Monitor quality metrics, identify trends, and drive continuous improvement initiatives.
• Collaborate with Manufacturing, Engineering, Validation, and Regulatory teams to resolve quality issues.
• Ensure compliance with GMP, FDA regulations, ISO standards, and company quality procedures.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• 3–5 years of Quality Engineering experience in a regulated manufacturing environment.
• Strong knowledge of GMP/cGMP, FDA regulations, and quality systems.
• Experience with CAPA, Deviations, Non-Conformance (NCR), Change Control, and Root Cause Analysis.
• Hands-on experience supporting IQ/OQ/PQ, process validation, or equipment qualification.
• Familiarity with FMEA, 5 Why, Fishbone, SPC, and Lean/Six Sigma methodologies.
• Experience with quality management systems such as TrackWise, MasterControl, Veeva, or similar is preferred.
• Excellent documentation, communication, and cross-functional collaboration skills.