Senior Quality Systems Engineer

Intuitive•Sunnyvale, CA

23d

About The Position

Primary Function of Position The Senior Quality Systems Engineer leads Quality/Regulatory business process owners and subject matter experts (SMEs) to identify business capability needs and opportunities for efficiency through automation. This role develops and delivers technology solutions that enhance productivity, simplify processes, and support compliant Quality operations.The ideal candidate has experience championing Quality technology needs in collaboration with IT and other technical teams and brings a strong combination of business and technical expertise. This role contributes directly to Quality systems initiatives by shaping business systems projects and overseeing the implementation, enhancement, and maintenance of electronic Quality Management Systems (eQMS) and other Quality-related applications.The individual will understand current Quality process complexities, how they flow through existing technology platforms, and help design future-state solutions that align with the organization's growth strategy. The role involves requirements understanding, system configuration, enhancements, testing, defect identification, and documentation, as well as participation in software architecture and design reviews to ensure functional, operational, and regulatory requirements are met. The position requires effective communication with management and subordinates regarding requirements, progress, and outcomes.

Requirements

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.
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.

Nice To Haves

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.

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.