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ESSENTIAL

DUTIES and

RESPONSIBILITIES

Establish, implement, and maintain quality system requirements in compliance with internal procedures, customer requirements, and applicable regulations (ISO 9001, ISO 13485); support APQP activities and PPAP submissions for new and revised products. Serve as the primary quality liaison between East West Wisconsin (EWW), customers, and internal departments (Engineering, Production, Supply Chain) to drive ongoing quality excellence and ensure the voice of the customer is represented throughout the product lifecycle. Monitor and report key quality performance metrics (e.g., DPPM, yield, scrap/rework rates, complaint trends) to plant management providing data-driven recommendations for improvement. Lead quality planning activities for new and existing products and processes, including the development of Process Flow Diagrams, Control Plans, and Failure Mode and Effects Analyses (FMEA/PFMEA), ensuring alignment with customer and regulatory requirements. Lead and support continuous improvement initiatives using Lean, Six Sigma (DMAIC), Kaizen, and other quality tools to enhance process efficiency, reduce defects, and drive down Cost of Poor Quality (COPQ) encompassing scrap, rework, and field failures. Compile, review, and maintain FDA Device History Record (DHR) data and other regulatory documentation; support Risk Management activities across quality system elements in compliance with ISO 13485 and 21 CFR 820 as applicable. Manage the customer complaint and nonconforming material (NCM/NCMR) processes, including disposition decisions (use-as-is, rework, scrap); coordinate with cross-functional teams to ensure timely, accurate, and complete records. Lead thorough root cause investigations on product quality issues and customer complaints using structured problem-solving methodologies (8D, 5-Why, Fishbone), ensuring effective containment and timely resolution. Initiate, manage, and close Corrective and Preventive Actions (CAPAs), verifying root cause identification, implementing sustainable solutions, and confirming effectiveness through follow-up data analysis and re-audit activities. Qualifications

PREFERRED QUALIFICATIONS

Education, Experience, Knowledge & Skills:

Bachelor's degree in engineering or a closely related discipline or minimum five years of experience in a quality related field. Working knowledge of disciplined problem-solving methodologies including 8D, Corrective Action Reports, 5 Whys, Cause-effect or fishbone diagrams, and flow diagrams. Basic component knowledge. Strong interpersonal skills that include group facilitation and conflict management as well as good oral and written communication skills. Working knowledge of

ISO 9001

requirements. Working knowledge of

ISO 13485

requirements. An understanding of IPC solder requirements. Internal Auditor Training. Strong computer skills Microsoft Office (Excel, Word, PowerPoint, Outlook). An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. 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Find & Apply For Validation Engineer Jobs in Whitewater, Wisconsin

Quality Engineer

Quality Engineer