Quality Engineer

Where people matter. East West, a trusted Integrated Manufacturing Solutions (IMS) company, and Vexos, a global provider of Electronics Manufacturing Services (EMS) and Custom Material Solutions (CMS), have joined forces to deliver exceptional manufacturing and supply chain solutions. Together, we partner with some of the world’s most recognizable brands and disruptive innovators, supporting diverse markets including industrial, medical, computing, communications, aerospace, defense, space and automotive.

The Quality Engineer acts as the key liaison between Engineering, Production, and the Customer, ensuring effective communication on quality issues, program priorities, process audits, and other critical matters. This role is responsible for maintaining strong alignment across departments while supporting customer satisfaction and product quality.

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.