Quality Systems Engineer | ISO 13485 & Lean Six Sigma

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

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.