Supplier Quality Engineer (medical device)

Supplier Quality Engineer – Medical Device Location: Delaware (Onsite) Duration: 12-Month Contract We are seeking a Supplier Quality Engineer to support supplier qualification, process validation, and ongoing supplier performance for complex Class II/III medical devices. This role works cross-functionally with R&D, Design Assurance, Regulatory, Operations, and Supplier Engineering to ensure quality and compliance throughout the supply chain. Key Responsibilities Lead supplier part qualification to support development and commercial launch schedules Execute supplier process validations (IQ/OQ/PQ) and capability studies Conduct GR&R studies, SPC monitoring, and statistical analysis Develop test methods, inspection plans, and measurement fixtures Support creation and revision of component specifications, print reviews, and GD&T interpretation Analyze and disposition supplier nonconformances Lead root cause investigations and drive corrective/preventive actions (CAPAs/SCARs) Provide technical support to Receiving Inspection and manufacturing Plan, schedule, and perform on-site supplier audits (process, QMS, special process) Assess supplier compliance to FDA QSR 21 CFR Part 820, ISO 13485, ISO 9001 Prepare audit reports, identify gaps, and verify corrective action implementation Evaluate supplier risk level and maintain approved supplier records Conduct supplier monitoring and re-evaluation audits as required Support PFMEA, process control plans, and supplier quality agreements Monitor supplier performance metrics and present risks to leadership Identify and execute continuous improvement projects using Lean/Six Sigma techniques #J-18808-Ljbffr Intellectt Inc