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
