Senior Quality Engineer - ISO 9001/13485 & Lean Leader

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

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