Senior Software Validation & Quality Lead

Edwards Lifesciences

Salt Lake City (UT)

On-site

USD 120,000 - 150,000

Full time

8 days ago

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Job summary

Edwards Lifesciences in Draper, UT seeks a Senior Quality Engineer, Software Validation to lead software-quality initiatives across manufacturing and engineering teams. You will own validation strategies, develop ESS, support protocols, and ensure documentation meets quality and regulatory standards.

This role partners with cross-site councils, reviews software specs, and mentors teams in lifecycle controls, risk assessment, and CAPA processes.

Qualifications

Bachelor's or Master's degree in engineering, science, CS, or information systems with relevant experience.
Experience in software quality, software validation, computer system validation, or lifecycle activities in a regulated manufacturing environment.
Experience in highly regulated environments.

Responsibilities

Lead and manage software-quality and validation requests from manufacturing, engineering, and other cross-functional teams.
Serve as a software process owner and approver for production and non-product software validations.
Develop, review, maintain, and approve Edwards Software Specifications (ESS) and other lifecycle documentation.
Support cross-functional teams in developing software-validation protocols, executing testing, documenting results, and completing validation reports.
Investigate software-quality and compliance issues, including CAPAs, nonconformances, and validation failures.