Quality Engineer: Validation, Risk & Compliance

Regulatory Jobs; Madison (WI); On-site; USD 79,000 - 97,000; Full time

Job summary

Envista’s Orascoptic team seeks a Quality Engineer to lead validation and risk management for new products and sustaining engineering. You will serve on cross‑functional teams to ensure regulatory and quality system compliance across development, manufacturing, and support functions.

You will apply DOE, FMEA, CAPA, and data analysis techniques while collaborating with R&D, operations, and procurement to drive quality improvements. Domestic travel may be required.

Qualifications

• Knowledge of medical device quality system requirements, ISO, GMP and relevant standards.
• Experience applying validation, design controls, risk management, CAPA, and statistics in manufacturing.
• Ability to lead cross‑functional teams and communicate effectively.
• Travel as required; proficiency with regulatory audits and documentation.

Responsibilities

• Develop and execute IQ/OQ/PQ validation protocols for equipment, processes, and software.
• Prepare validation reports and analyze data for trends and improvements.
• Ensure validation activities comply with regulatory requirements and standards.
• Lead or support investigations for nonconformances, CAPAs, and supplier issues.
• Apply DOE, FMEA, capability analysis, sampling plans, and trend analysis.
• Support supplier qualification, audits, and supplier corrective actions.
• Participate in audits and provide evidence-based responses.
• Collaborate with R&D, Manufacturing, Operations, Regulatory, and Quality Systems.
• Mentor junior Quality Associates and support continuous improvement.

Skills

Quality systems knowledge

Statistical analysis

DOE

FMEA

Root cause analysis

Cross-functional leadership

Technical writing

English proficiency

Process validation

Education

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

Quality Engineer certification or equivalent

Tools

MasterControl

Oracle

Job description

Envista’s Orascoptic team seeks a Quality Engineer to lead validation and risk management for new products and sustaining engineering. You will serve on cross‑functional teams to ensure regulatory and quality system compliance across development, manufacturing, and support functions.

You will apply DOE, FMEA, CAPA, and data analysis techniques while collaborating with R&D, operations, and procurement to drive quality improvements. Domestic travel may be required.