Leah Simpson
- Role
- Validation Engineer at Intuitive
- Location
- Belmont, CA, US
- LinkedIn followers
- 500 followers
About Leah Simpson
Friendly, detail oriented, and analytical, with a desire to solve problems and make work…
Experience
Validation Engineer
Jan 2022 — Present
Primary Function of Position: Responsible for validating quality systems software applications to meet internal procedures and external regulatory requirements. Write high quality technical documentation to ensure validation documentation are audit ready. Work closely with cross-functional teams to document validation deliverables throughout the software development life cycle and during software maintenance phase. · Drive software validation projects to completion for new applications as well as existing applications via change control. · Work collaboratively across functions with Quality, Development, program managers, and business users to develop content for validation deliverables. · Review and edit validation documents for approval such as validation plans, concept approval forms, regulatory assessments, architecture documents, risk assessments, product and functional requirements and specifications, trace matrices, code review documents, protocols, and reports. · Submit high-quality, consistent, validation documentation into document control system for approval within project timelines. · Work with core team to develop project scope, intended use, and risk analysis for categorizing each software change as major, moderate, or minor. · Work with quality team in updating documents to maintain auditability and compliance with internal procedures and external regulations and standards. · Follow internal software validation procedures, escalate process issues, and follow best practices to engage and communicate effectively with stakeholders throughout the project lifecycle.
Skills
- Data Integrity
- Microsoft Excel
- Tensile Testing
- Laboratory Skills
- Rems
- Materials Science
- Cell Culture
- Investigation
- Powerpoint
- Scanning Electron Microscopy
- Microsoft Word
- Fluorescence Microscopy
- Patience
- Nx
- System Administration
- Management
- Animal Care
- Research
- First Aid
- Edms
- Biotechnology
- Microsoft Office
- Laboratory
- Laboratory Research
- Gxp
- Biomaterials
- Customer Service
- Lathe
- Microscopy
- Childcare
- Labview
- Softmax Pro
- Empower
- Trackwise
- Public Speaking
- Basic Photoshop
- Veeva
- Statistics
- Excel
- Instron
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