Software Validation Quality Assurance Engineer
3 days ago
At Intuitive Surgical, we are dedicated to expanding the potential of physicians to heal without constraints. Our mission is to provide innovative, minimally invasive care solutions that improve patient outcomes and enhance the lives of healthcare professionals.
We are a pioneer and market leader in robotic-assisted surgery, and we strive to foster a diverse and inclusive team that is committed to making a difference in the world of healthcare.
Job DescriptionWe are seeking a highly skilled Software Validation Quality Assurance Engineer to join our team. As a key member of our Digital and Data Products group, you will be responsible for ensuring the quality and compliance of our GxP computerized systems.
Your primary focus will be on validating and verifying our software applications to ensure they meet the required regulatory standards. You will work closely with our project teams to develop and implement validation strategies, and you will be responsible for creating and maintaining validation documentation.
This is a unique opportunity to join a dynamic and growing team and to contribute to the development of innovative medical device software solutions.
- Responsible for oversight of all GxP regulated computerized systems at all applicable points of the computerized system lifecycle.
- Ensure compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements.
- Provide oversight of validation activities, lead the development and approval of validation documentation, risk assessments, work with project teams to determine which elements should be validated and conduct impact assessment of proposed changed to computerized systems.
- Perform and/or direct GxP computerized system validation projects in compliance with 21 CFR 820, ISO 13485, ISO 62304, 21 CFR Part 11, Annex 11 and Data Integrity.
- Ensure that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and Intuitive Surgical policies and procedures.
- Support systems and new product introduction by serving as a Quality resource, providing expertise, problem solving, and strategies for problem prevention.
- Participated as the Product Quality representative in project team activities and process design to ensure cGxP compliance and interdepartmental consistency within the validation program.
- Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.
- Coordinate and provide training and/or opportunities for career development of others.
- Drive a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences.
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