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Software Validation Engineer in Schaumburg, IL at SNI Technology

Date Posted: 6/8/2022

Job Snapshot

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.
  • Build the processes from scratch.
  • 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 devices
  • Bachelor’s Degree