Quality Engineer Resume Example

ASQ CERTIFIED QUALITY ENGINEER (CQE) and Lean Six Sigma Green Belt Professional with 3+ years of experience in manufacturing and medical device industries, working in a regulated environment performing Root cause analysis, QECR's, Gage R&R and Process & Packaging Validation and Project management *Good experience working on NCR, QECR, GRN and Quality holds *Experience with engineering design, document control, design control and process control in both engineering and manufacturing departments *Good understanding of ISO 9000, ISO 13485, FDA 21 CFR 820 and FDA Quality systems *Working knowledge on writing documents like Standard Operating Procedures(SOP's), work instructions, technical files *Experience performing validations (IQ, OQ, PQ), CNC Machining and MRB *Familiar with drafting standards, blue print and technical drawing reading, Design of Experiments (DOE), GMP, GD&T, QSR and Lean Manufacturing Techniques, creating and maintaining DHF, DMR and NCR *AutoCAD Certified associate, proficient in CATIA and Creo, Computer Aided Drafting (CAD) *Strong experience working on Statistical Process Control (SPC), 5S, kaizen, Gage R&R Studies, Test Method validation and Process Monitoring *Strong skills with Risk Assessment, Corrective Action and Preventive Action (CAPA) investigation, Failure Mode Effect Analysis (FMEA)

AutoCAD, blue print reading, CATIA, CNC, documentation, drafting, cleaning equipment, experiments, forms, GMP, http, Inspection, IE, inventory, IQ, lathes, layout, machinery, machining, manufacturing process, manufacturing processes, materials, meetings, Access, Excel, Office, Outlook, Power Point, Windows, MS Word, works, Minitab, OS, OQ, organizing, packaging, personnel, PQ, Problem solving, Progress, project plans, PUBLICATIONS, quality, risk assessment, Sample preparation, Six Sigma, Statistical process control, strategy, Troubleshooting, Visio