QS Validation Engineer

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timePosted 14 days ago location United States salarySalary undisclosed
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Job Description

Job Title QS Validation Engineer 2 - CSV Location Sunnyvale, CA 6 months contract 8+yrs experience required Looking from pacific zone only Primary Function of Position Intuitive Surgical is seeking a strong, experienced, collaborative QS CSV (Computer System Validation) individual to ensure that Intuitive Surgical computerized and automation systems are in full compliance with regulatory requirements, company policies, and procedures. The QS CSV individual will serve as a subject matter expert to provide compliance requirements input to cross-functional teams' CSV projects. She will collaborate with business partners to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processes Roles Responsibilities bull Participates on cross functional teams as the SME for ISI CSV projects including inquiries pertaining to the interpretation of FDA and other regulatory requirements for computer system validation. bull Provides management with updates on projects, the health of the CSV process, and when necessary, communicates risk-based issue escalations. bull Is expected to stay current with US and international regulations, industry standards, and emerging topics (e.g., cybersecurity) pertaining to computer software validation. bull Provides value-added guidance during the design, deployment, maintenance, and retirement of IT computer systems. This guidance applies to all systems developed in-house, developed by contractors, and off the shelf (OTS) software. May perform supplemental research to provide options for compliant solutions to barriers encountered during validation activities. bull May review and approve software validation documentation to ensure documentation is compliant with IT procedures and all applicable quality system regulations or standards. bull Participates with IT project teams in creating and approving various documentation for IT projects including the following o Regulatory Assessment for determination of GxP and Part 11 relevance o Validation Master Plan o Technical documentation (e.g., User Requirement, Functional Requirements, Design Specification) o Requirements Trace Matrix o Risk Assessment o IQOQPQ Protocols and Reports o Validation Summary Report bull Participates in CSV related activities for CAPA Skills, Experience, Education, Training bull Bachelor's degree in Computer Science, Information SystemsTechnology, or Engineering Technology, Science. bull Ten plus (at least 4+) years' experience within a dedicated a CSV or product software validation role. Proficient in system and software validation engineering processes, software risk management, software VV methodologies, and software configuration management. bull Five plus (at least 3+) years of experience in an FDA regulated environment with knowledge of regulatory compliance pertaining to software validation in IT Infrastructure and Enterprise Systems supporting business, manufacturing, or quality management (e.g., Agile, SAP, MES) plus in-house developed software applications. bull Must be able to manage multiple projects and meet established timelines bull Demonstrated understanding of FDA Quality System Regulation and ISOEU standards pertaining to computer software validation (e.g., 21CFR Part 820, subpart G Production and Process Controls, 820.70 (i)) software validationautomated processes 21 CFR Part 11 Electronic Records Signatures ISO 13485, 7.5.2 Validation of processes for production and service provision, section 7.5.2.1 General requirements). bull Proven ability of working in a cross-functional team environment with excellent interpersonal and communication skills. bull Ability to influence others through persuasive, logical, and constructive debate based on data. bull Excellent analytical, verbal, writing, prioritization, and multitasking skills. bull Prefer experience andor training in software quality engineering principles, GAMP principles or in Information Systems (IS)Technology related to compliance within a regulated industry.