NEW #JOB - Quality Engineer in New York, NY

NEW #JOB - Quality Engineer

The Wellington Group has been engaged to find an experience Quality Engineer with experience ranging from compliant investigations to CAPA and Continuous Improvement. Put your FDA regulated, QA Engineering experience to work in an exciting new job with great growth opportunity!The Quality Engineer is directed at enabling complaint investigations, nonconforming product investigations, and phase 2 out of specification investigation (Phase 2 OOS), process validation and trend analysis within the organization for CAPA, continuous improvement, and/or cost savings. Requirements:? Establishes strategies, determines priorities, project goals and assess results by working with Quality and Manufacturing leadership on CAPA, Complaint, and Nonconforming Material investigations and process validation activities? Ability to communicate, coach and mentor suppliers through supplier incoming nonconformance investigation and supplier CAPA investigations? Identifying root cause and implementing CAPA to prevent recurrence? Improves baseline performance relative to cost, quality, cycle time and customer satisfaction? Coordinates and drives improvement projects and initiatives by meeting/exceeding business needs? Reduces systemic manufacturing quality defects and improves quality systems by leading organization efforts at all levels? Identifies and eliminates process waste by continually driving continual improvement and sustainable results? Understands customer requirements and translates these into actions for quality and process improvement by interacting with customers and teams? Ensures improvement team targets are consistently met or exceeded by using Lean-Six Sigma principles and best available manufacturing methods and practices? Identifies opportunities and improves business process by training and coaching teams and functional leaders in applying Six SigmaThe qualified candidate will have:? BS Degree in Engineering? 5+ years of experience in OTC, Pharmaceuticals or Consumer Goods in a cGMP manufacturing facility? FDA 21 CFR 211 compliance experience required ? Experience in quality and process improvements using Lean / Six Sigma DMAIC and DFSS methodologies ? Combination of project management and business process analysis? Hands-on experience with methods development and methods validation for analytical testing equipment and procedures? Experience with liquids, creams, ointments is ideal? Computer Skills -- Minitab, Microsoft Excel, Word, Power Point, and Adobe AcrobatIndustry: QA Engineer, Engineer, CAPA, DMAIC, OOS, FDA, process validation, root cause, investigations, continuous improvement, SPC, Lean, Six Sigma, liquids, creams, ointments, OTC, CPGJob Code: [removed phone]-MH2322Location: New YorkApply directly at: http://www.maxhire.net/cp/?E55F68361D43515B7D52182B77501F[removed phone]BDon't wait, apply with The Wellington Group today!(all information will be held in the strictest of confidence)The Wellington Group ( http://www.twgrecruiters.com ) [removed phone]

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