Intellectt Inc
Quality Engineer - Medical Devices at Intellectt Inc Chicago, IL
Intellectt Inc, Chicago, Illinois, United States, 60290
Quality Engineer - Medical Devices job at Intellectt Inc. Chicago, IL.
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.
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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.
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