Senior Quality Systems Engineer

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 organizations 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.

Essential Job Duties

• 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 accordance with 21 CFR Part 11 and ISO 13485compliant 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.

Qualifications :

Required Skills and Experience (Specific skills knowledge and experience that an individual must possess in order to successfully perform in job)

• 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.

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time