Senior Quality Engineer: ISO 13485/9001 & Lean

EAST WEST MANUFACTURING LLC; Whitewater (WI); On-site; USD 75,000 - 100,000; Full time

Job summary

East West Manufacturing LLC, in Whitewater, WI, seeks an experienced Quality Engineer to bridge Engineering, Production, and Customer needs, ensuring product quality and regulatory compliance.

The role focuses on maintaining ISO 9001 and ISO 13485 aligned quality systems, leading APQP/PPAP activities, and driving continuous improvement through Lean, Six Sigma, DMAIC. Strong problem-solving and communication are essential.

Qualifications

• Bachelor's degree in engineering or related field; five years of quality experience preferred.
• Strong problem-solving and analytical abilities.
• Effective written and verbal communication.

Responsibilities

• Develop, implement, and maintain quality system requirements per ISO 9001 and ISO 13485.
• Lead PPAP submissions and APQP activities for new products.
• Coordinate with Engineering, Production, and Supply Chain to drive quality excellence.
• Lead root cause investigations using 8D, 5-Why, and Fishbone methodologies.
• Manage CAPAs and ensure effective corrective actions across functions.

Skills

Strong communication

Team collaboration

Process improvement

Education

Bachelor's degree in engineering or related field

Tools

8D problem solving

5 Whys

Fishbone diagram

FMEA

DMAIC

Control Plans

Job description

East West Manufacturing LLC, in Whitewater, WI, seeks an experienced Quality Engineer to bridge Engineering, Production, and Customer needs, ensuring product quality and regulatory compliance.

The role focuses on maintaining ISO 9001 and ISO 13485 aligned quality systems, leading APQP/PPAP activities, and driving continuous improvement through Lean, Six Sigma, DMAIC. Strong problem-solving and communication are essential.