Senior Software Validation Quality Engineer

Edwards Lifesciences Gruppe; Salt Lake City (UT); Hybrid; USD 110,000 - 140,000; Full time

Job summary

Edwards Lifesciences seeks a Senior Quality Engineer, Software Validation to lead software-quality initiatives for production and non-product software at the Draper facility. You will partner with manufacturing and engineering to define validation strategies, develop ESS, and ensure lifecycle documentation meets quality and regulatory requirements.

You’ll own validation activities from assessment through approval, support CAPAs, deviations, and investigations, and contribute to global

Qualifications

• Bachelor's degree in an engineering, scientific, computer science, or information systems field with at least 4 years of relevant experience; OR Master's degree with at least 3 years of relevant experience.
• Experience in software quality, software validation, computer system validation, or software lifecycle activities in regulated manufacturing environments.
• Experience with risk management, CAPA, deviations, and validation reporting.

Responsibilities

• Lead software-quality and validation requests from manufacturing, engineering, and cross-functional teams.
• Develop, review, maintain, and approve Edwards Software Specifications (ESS) and validation documentation.
• Support validation protocols, execute testing, document results, and complete validation reports.
• Investigate software-quality issues, CAPAs, nonconformances, and audit observations.
• Participate in cross-site governance councils and communicate Draper requirements to global teams.

Skills

Software quality

Software validation

CAPA investigations

Root cause analysis

Risk management

Stakeholder management

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in engineering/science/CS/IS

Master's degree in engineering/science/CS/IS

Tools

LabVIEW

VBA

Job description

Edwards Lifesciences seeks a Senior Quality Engineer, Software Validation to lead software-quality initiatives for production and non-product software at the Draper facility. You will partner with manufacturing and engineering to define validation strategies, develop ESS, and ensure lifecycle documentation meets quality and regulatory requirements.

You’ll own validation activities from assessment through approval, support CAPAs, deviations, and investigations, and contribute to global