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Senior Software Validation Quality Engineer

4 months ago

Sunnyvale, United States Intuitive Surgical Full time
Job Description

Primary Function of Position

This 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.