Software Validation Engineer

Job Description

• 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.

• 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