Quality Engineer - Validation & CAPA Leader

Envista Holdings Corporation; Madison (WI); On-site; USD 79,000 - 97,000; Full time

Job summary

Envista Holdings Corporation in Madison, Wisconsin seeks a Quality Engineer to lead validation, design controls, risk management, and quality system compliance across new product development and operations.

You will work with R&D, manufacturing, regulatory, and procurement to ensure products meet regulatory and customer requirements, perform CAPA investigations, and apply DOE/FMEA to drive improvements. This role requires strong communication in English and ability to travel as needed.

Qualifications

• Bachelor’s degree in one of several engineering fields with regulated medical device exposure preferred.
• 2–5 years of quality experience in a regulated industry, preferably medical devices.
• Hands-on experience applying validation, design controls, risk management, investigations, CAPA, statistical methods, and quality system requirements in manufacturing.
• Quality Engineer certification or another relevant professional certification preferred.

Responsibilities

• Develop and execute validation protocols for equipment, processes, and systems.
• Lead investigations involving nonconformances, CAPAs, and supplier quality issues with root-cause analysis.
• Apply DOE, FMEA, capability analysis, sampling plans, and trend analysis to improve products and processes.
• Provide supplier quality support for qualification, audits, validations, change assessments, and SRAs.
• Collaborate with R&D, Manufacturing Engineering, Operations, Regulatory, Procurement, and Quality Systems across the product lifecycle.

Skills

Quality systems

Regulatory requirements

Statistical methods

DOE & FMEA

Technical writing

Cross-functional

English communication

Travel ability

Education

Bachelor’s degree in Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems Engineering

Tools

MasterControl

Oracle

Job description

Envista Holdings Corporation in Madison, Wisconsin seeks a Quality Engineer to lead validation, design controls, risk management, and quality system compliance across new product development and operations.

You will work with R&D, manufacturing, regulatory, and procurement to ensure products meet regulatory and customer requirements, perform CAPA investigations, and apply DOE/FMEA to drive improvements. This role requires strong communication in English and ability to travel as needed.