Quality Engineer

East West Manufacturing, LLC; White Water (AL); On-site; USD 85,000 - 105,000; Full time

Job summary

East West Manufacturing, LLC is seeking an experienced Quality Assurance professional to lead quality systems and regulatory compliance at our Wisconsin facility. You will drive APQP/PPAP alignment, manage DHR data, and coordinate with engineering, production, and supply chain to secure compliant, high-quality products.

The role emphasizes problem solving with 8D/5-Why/Fishbone tools, Lean Six Sigma and Kaizen for continuous improvement, and strong communication with customers and internal teams

Qualifications

• Bachelor’s degree in engineering or related discipline or 5+ years in a quality role.
• Knowledge of 8D, 5 Whys, root-cause diagrams (fishbone), and flow diagrams.
• Familiarity with ISO 9001 and ISO 13485 requirements.
• Internal Auditor Training preferred.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Establish, implement, and maintain quality system requirements per ISO 9001/13485.
• Serve as primary quality liaison between East West Wisconsin, customers, and internal departments.
• Monitor key quality metrics and provide data-driven improvement recommendations.
• Lead quality planning for new/existing products (FMEA/PFMEA, CP, PFD).
• Lead continuous improvement using Lean, Six Sigma (DMAIC), Kaizen and COPQ reduction.
• Maintain FDA DHR data and other regulatory documentation; support Risk Management per ISO 13485/21 CFR 820.
• Manage complaints and NCM/NCMR processes with cross-functional coordination.
• Lead root cause investigations (8D, 5-Why, Fishbone) and CAPA effectiveness checks.

Skills

Lean Six Sigma

8D Problem Solving

5 Whys

Fishbone Diagram

Interpersonal Skills

ISO 9001 Knowledge

ISO 13485 Knowledge

Microsoft Office

Education

Bachelor’s degree in engineering or related discipline

Tools

Microsoft Office

Job description

Job Details

Level: Experienced, Job Location: Whitewater WI - Whitewater, WI 53190, Position Type: Full Time, Education Level: 4 Year Degree, Job Shift: Day,

Overview

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.

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.

PREFERRED QUALIFICATIONS

• 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).

Reasonable Accommodations

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.

Equal Opportunity

We are an equal-opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.