Quality Engineer – Medical Devices

Job Title: Quality Engineer – Medical Devices

Location: Chicago, IL (Onsite)

Duration: 12-Month Contract (with potential for extension)

Key Responsibilities:

• Support Quality System maintenance in accordance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulatory standards.
• Lead and support Non-Conformance (NC) and Corrective and Preventive Action (CAPA) investigations; perform root cause analysis using tools like 5 Whys, Fishbone, FMEA.
• Participate in validation activities (IQ/OQ/PQ) for equipment, processes, and software.
• Review and approve Engineering Change Orders (ECOs), Deviations, and Document Changes.
• Provide quality input during Design Control and Risk Management processes.
• Perform internal audits and support regulatory inspections (FDA, ISO, MDSAP).
• Collaborate with manufacturing, R&D, and supply chain teams to ensure product quality.
• Support supplier quality activities and perform incoming inspection audits when required.
• Create and revise Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Monitor product performance trends and support continuous improvement projects.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field (Biomedical/Mechanical preferred).
• Minimum 3-5 years of experience as a Quality Engineer in medical device or regulated industries.
• Solid understanding of FDA regulations, ISO 13485, ISO 14971, and risk-based approaches.
• Experience with CAPA systems, Change Control, Complaint Handling, and Root Cause Investigations.
• Familiarity with tools such as TrackWise, MasterControl, Greenlight Guru, or similar QMS platforms.
• Proficient in MS Office, especially Excel and Word; knowledge of Minitab is a plus.
• Certifications like CQE, Six Sigma, or Lean are desirable.