Quality Engineer: Validation, Risk & Supplier Quality

Envista; Kentucky; On-site; USD 79,000 - 97,000; Full time

Job summary

Envista in Kentucky seeks a Quality Engineer to independently lead validation activities and drive quality improvements across new product development, sustaining engineering, and manufacturing.

You will apply DOE, FMEA, and statistical methods, support investigations, supplier quality, and design/process changes while ensuring compliance with regulatory, quality systems, and customer requirements in a regulated medical device context.

Qualifications

• Bachelor's degree in engineering (Biomedical, Mechanical, Manufacturing, Industrial, Electrical, Chemical, Materials, or Systems).
• 2–5 years of quality experience in a regulated industry, preferably medical devices.
• Hands-on experience with validation, design controls, risk management, investigations, CAPA, statistics, and quality system requirements.

Responsibilities

• Lead validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
• Prepare validation reports and interpret data to identify trends and improvements.
• Ensure compliance with regulatory requirements and quality system standards.
• Lead investigations for nonconformances, CAPAs, and supplier/ manufacturing quality issues; conduct root cause analyses.

Skills

Statistical analysis

DOE

FMEA

CAPA

Quality systems

Education

Bachelor's degree in engineering

Tools

MasterControl

Oracle

eQMS

Job description

Envista in Kentucky seeks a Quality Engineer to independently lead validation activities and drive quality improvements across new product development, sustaining engineering, and manufacturing.

You will apply DOE, FMEA, and statistical methods, support investigations, supplier quality, and design/process changes while ensuring compliance with regulatory, quality systems, and customer requirements in a regulated medical device context.