Primary Location: United States-California-Sunnyvale-US-CA-Sunnyvale
Requisition ID: 201209
Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
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. S/he will collaborate with business partners to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processes. May serve as a backup for Quality Systems CSV contact to management and business partners involved in CSV projects.
Roles & Responsibilities:
- 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.
- 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.
- Support CSV management by aligning with 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.
- May review and approve software validation documentation to ensure documentation is compliant with IT procedures and all applicable quality system regulations or standards.
- May participate or lead 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:
- Regulatory Assessment for determination of GxP and Part 11 relevance
- Validation Master Plan
- Technical documentation (e.g., User Requirement, Functional Requirements, Design Specification)
- Requirements Trace Matrix
- Risk Assessment
- IQ/OQ/PQ Protocols and Reports
- Validation Summary Report
- Recommends continuous improvement activities to streamline validation processes.
- Works with CSV lead or manager to support CSV remediation activities.
- Participates in CSV related activities for internal and external audits.
- 25% of the role will be responsible for completing process improvements and the other 75% will be responsible for projects and CAPA work.
Skills, Experience, Education, & Training:
- Bachelor's degree in Computer Science, Information Systems/Technology, Engineering, Science, or Business.
- Eight plus (8+) 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.
- Four plus (4+) 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.
- 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 22.214.171.124 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, verbal, writing, prioritization, and multitasking skills.
- Prefer experience and/or training in software quality engineering principles, GAMP principles or in Information Systems (IS)/Technology related to compliance within a regulated industry.
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.