Under general direction, the Senior Software Validation Analyst will contribute to the full life cycle of software products for a growing Medical Device company. This position is responsible for ensuring the Quality system applications are fully functional and tested per the FDA regulations and localized governing bodies’ standards. Good leadership and communication skills are required for team collaboration, testing scenario feedback, and time management.
Principal Duties and Responsibilities
Facilitates medium complex software validation projects which align to defined procedures
Provides assurance that the solution remains in a validated state throughout its life cycle via change control activities
Supports multiple projects at a time but using solid time management and communication skills
Works collaboratively with project teams to keep them informed of validation/testing status, including any barriers
Works closely with the IT and Business stakeholders to support and resolve audit findings
Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders
Values team atmosphere and will jump in and assist with other activities and projects
Expected Areas of Competence
Understands SDLC Process in accordance with FDA 21 CFR Part 820, the Quality System Regulation, ISO 13485
Ability to prioritize/schedule activities to meet department goals and objectives
Ability to communicate with technical and non-technical personnel
Ability to use Testing Management tools like HPALM is desired
Education/Experience Requirements
Bachelor degree in Information Technology, Engineering, Science with 5+ years of related professional experience, or Bachelor and Master's with 4+ years related professional experience required
3+ years experience working on Computerized System Validation (CSV) activities
