Quality Engineer

EAST WEST WISCONSIN LLC; Whitewater (WI); On-site; USD 80,000 - 110,000; Full time

Job summary

East West Wisconsin LLC in Whitewater, WI is seeking an experienced Quality Engineer to drive quality across Engineering, Production and Supply Chain. You will lead APQP/PPAP, manage DHR documentation and CAPAs, and ensure regulatory alignment with ISO 13485 and 21 CFR 820.

Ideal candidates will bring Lean/Six Sigma experience, strong data skills, and a collaborative approach to improve process quality and customer satisfaction.

Qualifications

• Bachelor’s degree in engineering or related field.
• Minimum five years in a quality-related role.
• Experience with ISO 9001 and ISO 13485 requirements.
• Knowledge of APQP/PPAP processes and quality tools (8D, 5-Why, FMEA).
• Strong communication, teamwork and problem-solving skills.

Responsibilities

• Establish, implement, and maintain quality system requirements per procedures and regulations (ISO 9001, ISO 13485).
• Serve as primary quality liaison between EWW, customers, and internal departments.
• Monitor and report key quality metrics (DPPM, yield, scrap) with data-driven recommendations.
• Lead quality planning for new/existing products, including FMEA/PFMEA, CPPs and process flows.
• Drive continuous improvement using Lean, Six Sigma DMAIC, Kaizen and COPQ reduction.
• Maintain FDA DHR data and assist with risk management in ISO 13485 / 21 CFR 820.
• Manage customer complaints and nonconforming material processes and dispositions.
• Lead root-cause investigations (8D, 5-Why, fishbone) and ensure containment.
• Initiate and close CAPAs with effectiveness verification and follow-up.

Skills

Interpersonal skills

Facilitation

Communication

Conflict management

Education

Bachelor’s degree in engineering or a closely 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,

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.

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.

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.