Quality Engineer – Validation & Compliance Innovator

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

Benefits offered by this job

Annual bonus

Medical/dental/vision benefits

401K match

Job summary

Envista in Madison, Wisconsin is seeking a Quality Engineer to independently lead quality engineering and validation activities supporting new product development, sustaining engineering, and manufacturing. You will apply validation, design controls, risk management, and statistical methods to ensure regulatory and customer requirements are met.

Collaborating with R&D, Manufacturing, Regulatory, and Quality Systems, you will drive investigations into nonconformances and CAPAs, utilize

Qualifications

• Bachelor’s degree in a engineering field related to quality in regulated industry.
• 2–5 years of quality experience in medical devices or similar.
• Experience applying validation, design controls, risk management, CAPA and QMS requirements.

Responsibilities

• Develop and execute IQ/OQ/PQ validation for equipment, processes, and systems including software.
• Prepare validation reports and analyze data to identify trends and improvements.
• Ensure validation activities meet regulatory and industry standards.
• Act as Quality Engineering representative for NPD, sustaining, V&V, risk management, and change reviews.
• Lead investigations for nonconformances, CAPAs, and supplier/manufacturing quality issues.
• Apply QA tools (DOE, FMEA, capability analysis, sampling, trend analysis) to improve products and processes.
• Provide supplier quality support for qualification, audits, validations, and CAPAs.
• Participate in audits with technical documentation and evidence-based responses.
• Collaborate with R&D, Manufacturing, Operations, Regulatory, Procurement, and Quality Systems.
• Mentor junior Quality Associates and support continuous improvement.
• Follow SOPs, work instructions, and safety requirements.

Skills

Statistical methods

DOE

FMEA

CAPA

Validation

Quality systems

Root cause analysis

Problem solving

Cross-functional communication

Education

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

Tools

MasterControl

Oracle

MS Office

Job description

Envista in Madison, Wisconsin is seeking a Quality Engineer to independently lead quality engineering and validation activities supporting new product development, sustaining engineering, and manufacturing. You will apply validation, design controls, risk management, and statistical methods to ensure regulatory and customer requirements are met.

Collaborating with R&D, Manufacturing, Regulatory, and Quality Systems, you will drive investigations into nonconformances and CAPAs, utilize