Onsite Quality Engineer, Medical Device, Madison

Envista; Madison (WI); On-site; USD 73,000 - 89,000; Full time

Benefits offered by this job

Health & Wellbeing

Retirement & Financial Benefits

Life & Disability Insurance

Paid Time Off

Learning & Career Development

Job summary

Envista is seeking a Quality Engineer to independently lead validation activities across new product development, sustaining engineering, and manufacturing. You will serve as the Quality representative on cross-functional teams, applying design controls, risk management, and statistical methods to ensure product and process quality.

The role requires onsite presence in Madison, WI, with 2–5 years of quality experience in a regulated environment.

Qualifications

• Bachelor's degree in a related engineering discipline and 2–5 years quality experience in a regulated industry.
• Experience with validation, design controls, risk management, investigations, CAPA, statistics, and quality systems in manufacturing.
• Familiarity with FDA QSR/ISO 13485, GMP, and regulatory expectations; strong writing skills.

Responsibilities

• Lead validation activities for processes, equipment, software and test methods from planning to final reporting.
• Serve as Quality representative for NPD, sustaining engineering, verification/validation, risk management, and design/process changes.
• Lead investigations for nonconformances, CAPAs, supplier or manufacturing quality issues with root cause analysis and corrective actions.

Skills

Quality engineering

Validation

Design controls

Risk management

Statistical methods

FMEA

CAPA

Root cause analysis

Quality systems

Regulatory knowledge

Education

Bachelor's degree in Biomedical/Mechanical/Manufacturing/Industrial/Electrical/Chemical/Materials/Systems Engineering

Tools

MasterControl

Oracle

MS Office

Job description

Envista is seeking a Quality Engineer to independently lead validation activities across new product development, sustaining engineering, and manufacturing. You will serve as the Quality representative on cross-functional teams, applying design controls, risk management, and statistical methods to ensure product and process quality.

The role requires onsite presence in Madison, WI, with 2–5 years of quality experience in a regulated environment.