Intuitive Surgical Careers
QS Computer System Validation
Primary Location: United States-California-Santa Clara County-Sunnyvale
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Primary Function of Position:
Intuitive Surgical is seeking a strong, experienced, collaborative QS CSV 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 the subject matter expert to provide compliance leadership and oversight to cross-functional teams’ CSV projects. S/he will collaborate with business partners to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processes. Will serve as the primary Quality Systems CSV contact to management and business partners involved in CSV projects.
Roles and Responsibilities:
• Responsible for developing the CSV roadmap and further ISI policy for present and future QMS IT Infrastructures.
• Serves as the lead SME for ISI CSV projects; including inquiries pertaining to the interpretation of FDA and other regulatory requirements for computer system validation.
• Provides management with updates on projects, the health of the CSV process, and when necessary, communicates risk-based issue escalations.
• Is expected to stay current with US and international regulations, industry standards, and emerging topics (e.g., cybersecurity) pertaining to computer software validation.
• Provides compliant and pragmatic leadership to software validation projects throughout the computer system’s software development lifecycle including system retirement.
• 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.
• Reviews and approves software validation documentation to ensure documentation is compliant with IT procedures and all applicable quality system regulations or standards.
• Organizes or conducts training on software validation principles and Part 11 requirements.
• Exercises judgment in selecting methods and language to provide compliant solutions to address and document issues, which may arise during validation activities.
• 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 IQ/OQ/PQ Protocols and Reports
o Validation Summary Report
• Recommends and/or drives continuous improvement activities to streamline validation processes. Leads or supports CSV remediation activities.
• Serves as the CSV SME for internal and external audits.
• Bachelor's degree in Computer Science, Information Systems/Technology, Engineering, Science, or Business.
• Ten plus (10+) years’ experience within a dedicated a CSV or product software validation role. Proficient in system and software validation engineering processes, software risk management, software V&V methodologies, and software configuration management.
• Experience within CSV, product software validation or other quality area involving validation activities (e.g., process, equipment, or test methods validation).
• Five plus (5+) years of experience in an FDA regulated environment with strong 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.
• Experience in implementing large systems such as Trackwise, Supplier Collaboration tool, etc.
• Demonstrated understanding of FDA Quality System Regulation and ISO/EU standards pertaining to computer software validation (e.g., 21CFR Part 820, subpart G Production and Process Controls, 820.70 (i)) software validation/automated processes; 21 CFR Part 11 Electronic Records & Signatures; ISO 13485, 7.5.2 Validation of processes for production and service provision, section 18.104.22.168 General requirements).
• Proven ability of working in a cross-functional team environment with excellent leadership, interpersonal and communication skills. Proficient in presenting data to management.
• Ability to influence others through persuasive, logical, and constructive debate based on data.
• Excellent analytical, prioritization, and multitasking skills.
• Prefer Certified Software Quality Engineer (CSQE) from a professional society (e.g., ASQ CSQE) or professional certification or training in Information Systems (IS)/Technology related to compliance within a regulated industry.