Senior Quality Engineer – ISO 9001/13485 & Lean Excellence

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

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