Quality Engineer

EAST WEST WISCONSIN LLC; Whitewater (WI); On-site; USD 65,000 - 95,000; Full time

Job summary

East West Wisconsin LLC in Whitewater, WI is seeking an experienced quality professional to lead quality systems and regulatory compliance across ISO 9001/13485 and FDA 21 CFR 820. This role drives CAPAs, root-cause investigations, DHR documentation, and supplier quality activities while coordinating with Engineering, Production, and Supply Chain to ensure the voice of the customer is represented.

Strong problem-solving, Lean Six Sigma, and MS Office skills are essential; a bachelor’s degree or

Qualifications

• Bachelor’s degree in engineering or closely related discipline or minimum five years of experience in a quality related field.
• Experience with ISO 9001 and ISO 13485; familiarity with FDA 21 CFR 820 preferred.
• Strong problem-solving and data-driven decision making.

Responsibilities

• Establish, implement, and maintain quality system requirements per internal procedures and regulations (ISO 9001, ISO 13485).
• Serve as the primary quality liaison between departments to drive quality excellence and voice of the customer.
• Monitor and report key quality metrics (DPPM, yield, scrap/rework) to leadership with data-driven recommendations.
• Lead quality planning for new and existing products and processes (FMEA, PFMEA, Process Flow).
• Lead and support continuous improvement using Lean, Six Sigma, Kaizen to reduce COPQ.
• Compile and maintain FDA Device History Records (DHR) and regulatory docs; support risk management per ISO 13485/21 CFR 820.
• Manage customer complaints and nonconforming materials; coordinate with cross-functional teams for disposition.
• Lead root-cause investigations (8D, 5-Why, Fishbone) and ensure containment and resolution.
• Initiate, manage, and close CAPAs with verification of effectiveness.

Skills

Problem-solving

Communication

Lean Six Sigma

8D / 5-Why

Education

Bachelor’s degree in engineering or closely related discipline

Tools

MS Office Suite

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.

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.