Intuitive · 5 hours ago
Senior Quality Systems Engineer
Sunnyvale, CA
Full-time
Onsite
Senior Level, Lead/Staff
$150K/yr - $215K/yr
10+ years expIntuitive is a pioneer and market leader in robotic-assisted surgery, committed to enhancing minimally invasive care through technology. The Senior Quality Systems Engineer will lead initiatives to improve Quality operations by developing and implementing technology solutions that streamline processes and ensure compliance.
Health CareManufacturingMedical Device
Responsibilities
Lead Quality process owners and subject matter experts (SMEs) to assess business capability needs and deploy compliant technology solutions using enterprise computer systems by configuring and managing Quality system functions and modules, overseeing data entry and processing activities, and ensuring all system operations meet Quality and Regulatory compliance requirements
Collaborate with Quality stakeholders to identify and analyze business process issues and improvement opportunities, and evaluate the application of new or enhanced technology solutions
Translating functional and regulatory requirements into actionable business system solutions. Advise on how technology can improve Quality operations and decision-making while ensuring compliance with applicable laws, regulations, and standards
Gather, document, and analyze business requirements. Develop, review, and maintain requirements documentation, test plans, test cases, and traceability matrices etc. in accordance with 21 CFR Part 11 and ISO 13485–compliant quality management system processes. Coordinate delivery efforts to meet project milestones and objectives
Lead the resolution of operational and system issues by collaborating with IT, Quality, Regulatory teams, and external vendors. Ensure effective systems, integrations, and automations testing to meet validation, security, and compliance requirements, and support timely software deployments
Plan, execute, and evaluate comprehensive software performance, functionality, and validation testing to ensure systems meet quality standards, business requirements, and regulatory expectations
Independently troubleshoot complex application and system issues, perform root-cause analysis, and implement corrective actions to minimize operational disruptions
Lead software architecture and design discussions and promote best practices in code quality, testing strategies, and documentation standards
Work with Regulatory and eQMS databases and apply SQL (Structured Query Language) queries for data analysis and reporting
Design build and implement AI and machine learning solutions for Quality processes in collaboration with vendors and internal teams, ensuring compliance with Quality and regulatory standards while enabling innovation
Leverage experience with cloud-based applications and web development frameworks to architect and support solutions that manage and track product compliance data effectively
Communicate complex and time-sensitive information effectively to supervisors, peers, and subordinates using verbal, written, electronic, and in-person communication methods. Provide clear operational updates, guidance, and status reporting, and proactively keep management informed of progress, issues, and outcomes
Qualification
Required
Minimum of 10+ years of overall industry experience, including 5+ years of hands-on experience in the implementation, design, configuration, or administration of eQMS, Regulatory, or other Quality business systems
Preferred experience working in complex, multi-system integration environments and implementation of eQMS solutions supporting Supplier Quality, Product Quality, Field Actions, Non-Conformances, Document Control, Complaints, and CAPA processes
Experience working with enterprise business software systems, writing product and system requirements, performing process mapping, and developing standards, methods, or procedures to assess product quality and release readiness. Experience building multi-year improvement roadmaps
Strong knowledge of the Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC), with experience using project management methodologies such as Agile and Scrum. Experience with Red Hat OpenShift, GitHub, Jira and similar tools
Demonstrated ability to design and configure QA environments and tools, including version control systems, test management tools (e.g., HP ALM, ValGenesis), GxP (GMP, GDP) qualification activities, and defect tracking systems
Hands-on experience planning and executing end-to-end (E2E) testing and User Acceptance Testing (UAT), including development of test plans, test cases, protocols, defect management, and validation deliverables covering database impacts, functional, regression, negative, and usability testing
Advanced proficiency in scripting languages such as Python or VBScript to automate testing, data processing, system integrations, validation support, and analytics in regulated environments
Experience applying Artificial Intelligence and Machine Learning (AI/ML) techniques to support data analysis, process optimization, anomaly detection, and intelligent automation while ensuring transparency, validation, and compliance
Experience utilizing cloud platforms such as AWS and Microsoft Azure to deploy, configure, and support scalable, secure, and compliant infrastructure and integrations
Proven ability to troubleshoot complex issues across cloud environments, APIs, AI/ML components, eQMS, and Veeva RIM applications through structured root-cause analysis and corrective and preventive actions
Strong verbal and written communication skills with the ability to translate complex technical and analytical concepts into clear, concise, and effective communications for diverse business audiences
Ability to comprehend, articulate, and simplify complex business and technical challenges to support stakeholder alignment and informed decision-making
Excellent attention to detail, organizational skills, and the ability to manage multiple concurrent projects while collaborating effectively in cross-functional team environments
Benefits
Market-competitive compensation packages
Base pay
Incentives
Benefits
Equity
Company
Intuitive
Intuitive designs and manufactures robotic-assisted surgical systems.
10001+ employees
H1B Sponsorship
Intuitive has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (339)
2024 (238)
2023 (181)
2022 (285)
2021 (145)
2020 (138)
Funding
Current Stage
Public CompanyTotal Funding
$5MKey Investors
St. Cloud Capital
2003-04-30Post Ipo Equity
2000-06-23IPO
1996-01-01Seed· $5M
Leadership Team
Gillian Duncan
Senior Vice President, Professional Education & Program Services - Worldwide
Myriam Curet
Executive Vice President & Chief Medical Officer
Recent News
2025-12-11
2025-11-14
Company data provided by crunchbase