Senior Software Validation Quality Engineer - Sunnyvale California

Company: Intuitive
Location: Sunnyvale, California
Posted On: 01/28/2025

Job DescriptionPrimary Function of PositionThis position will report into Senior Manager - Product Quality Digital & CSA. The primary responsibility of this person is to represent PQ as a self-directed quality oversight on the GxP Computerized Systems Validation efforts globally across Intuitive sites around the world.Essential Job Duties

• Maintains responsibilities for ensuring GxP computerized systems operate within the framework of regulations (GxP, 21CFR11, etc.), applicable Quality Modules, and requirements defined in local procedures.
• Provide direct oversight for computer system validation from a quality assurance perspective to ensure quality and compliance requirements are met.
• Provide guidance on CSV validation issues and discrepancies. Support investigation of CSV defects and quality records (deviation, CAPAs).
• Review CSV Validation activities including deliverables from regulatory compliance standpoint.
• Provide support to external and internal audits related to computerized system validation activities.
• Advice a cross functional team in an efficient manner, including but not limited to excellent communication and time management skills to share responsibilities and expectations, and accomplishing goals throughout timelines.
• Help, establish and sustain computer system validation global policies and standards that incorporate industry best practices and are health authority compliant.
• Partnering with internal and external teams; sharing information to increase the collective understanding of QA and Compliance programs.
• Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5.
• Ensuring alignment of processes, procedures and methods across multiple organizations (internal and external).
• Ensuring systems are fully implemented and integrated with other quality management systems, site and global functions.
• Authoring and /or revising SOPs.
• Ability to provide guidance on revising validation documents and protocols.
• Administer applicable electronic systems.
• Assist as needed in audits and inspections.
• Interacts with senior internal personnel and external partners on significant matters often requiring coordination across facility locations.
• Contribute to projects related to CSV improvements.
• Support the Compliance team on computerized system audits to ensure compliant vendor/supplier management program and services.
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