Job Description
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.