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Software Validation Engineer

Company: SNI Technology
Location: Schaumburg
Posted on: November 17, 2021

Job Description:

Software Validation Engineer Software Validation Engineer will be a resource for validation and software lifecycle management and will be required to provide direction and hands on technical assistance on a variety of system validation projects. Work with Product Design and Development Process as it relates to Design Control, Computer Systems Validation and Verification, and Quality Systems. Essential Duties and Responsibilities:Responsible for guiding Software Validation team and developing/reviewing validation and verification deliverables (i.e., Validation Plans, Software Design Specifications, Risk Analysis, Test Plan & Protocols, Validation Summaries and Reports, etc.)Responsible for ensuring new and existing developments are compliant with procedures related to validation, validation master plans, software lifecycle management, software product design control, and change control with risk management.Assists with addressing software-related customer complaints and CAPAs.Responsible for overseeing compliance with regulatory requirement (e.g. HIPAA, GDPR, 21 CFR Part 11, etc.)Reviewing existing validation related QMS documents and developing new ones.Responsible for software related supplier approval and ongoing monitoring.Provide training on related subjects to team.Requirements: Experience with medical device quality systems including design control and Software development processes.Understanding of risk management and its application in design and quality systems.Understanding of 21 CFR 820; 21 CFR Part 11; ISO 13485, ISO 14971; GDPR and EU MDR requirements.3 years of experience in software systems and software validation processes and Quality Management System, specifically with medical devicesBachelor's DegreePlease submit resumes to

Keywords: SNI Technology, Schaumburg , Software Validation Engineer, IT / Software / Systems , Schaumburg, Illinois

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