Quality Engineer Jobs

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Role:Quality Engineer

Location:Warsaw, IN - Onsite

Duration:contract

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Must Have

Medical Devices, Process Validation, IQ/OQ/PQ, 21 CFR Part 11, Statistical Analysis Tools, Critical-to Quality (CTQ) Analysis, Inspection Techniques, SPC, Change Management System

•knowledge of basic quality tools, risk analysis, statistics (SPC), and inspection techniques

•Ability to read and understand engineering drawings

•Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ

•Specific experience with Test method Validation and Gage R&R

•Experience with root cause analysis and problem-solving for both technical and process issues

•Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003

•Good problem-solving skills through the use of quality and statistical tools

•Ability to read and understand engineering drawings

•Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), Critical-to Quality (CTQ) Analysis

•Knowledge of Quality System requirements, ISO and FDA requirements

•Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions & Proficient with Statistical Process Control concepts, process development, CNC programming terminology, and tooling design concepts

•Microsoft Office Suite and Project