Intuitive
Healthcare
SeniorQualityEngineer
Neural analysis suggests this role is
optimal for mid candidates.
“Senior Quality Engineer at Intuitive. Skills: Quality Engineering, Process Validation, Regulatory Compliance. Ensure manufacturing processes comply with quality standards. Perform follow-ups on notifications”
What You'll Achieve.
Defect reduction; Improve outcomes worldwide
Industry & Context.
Root Cause Analysis; Troubleshooting techniques
Use Personal Protective Equipment
What They're Looking For.
Must Have
3 years as Senior Engineer, 5 years process validations, 3 years quality audits medical products, Bachelor’s Degree - Any engineering degree, English - Advanced, Office Package - Advanced, SAP System - Intermediate, Minitab - Intermediate, Lean Manufacturing - 3 years, ISO-13485, 21CFR820 - 3 years, Troubleshooting techniques - 3 years, Six Sigma and statistical tools - 3 years
Nice to Have
Minitab - Desired
What You'll Do.
Ensure manufacturing processes comply with quality standards
Perform follow-ups on notifications
Monitor defect trends
Support corrective and preventive actions
Implement actions for defect reduction
Transition new products to site
Prepare trend reports
Perform analysis of major offenders
Follow up on Quality Notifications
Participate in process validations
Document validation results
Conduct improvement projects
Perform mentoring activities
Complete assigned trainings
Prepare performance self-assessment
Clarify quality controversies
Participate in Customer Complaint investigations
Review validation protocols
Approve validation protocols
Report nonconforming product
Follow up on raw material problems
Participate in audit preparation
Participate in audit development
How You'll Work.
Team & Collaboration
Production Supervisors; FQI Technicians; Corporate locations
Communication Scope
Quality controversies clarification
Process & Methodology
Project management, Project leader
Full Job Description
It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care , our technologies—like the da Vinci surgical system and Ion —have transformed how care is delivered for millions of patients worldwide. We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life. If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare , you’ll find your purpose here. Primary Function of Position: Ensure that manufacturing processes comply with quality standards performing follow-ups and monitoring the Notifications generated, process validations and defect trends, in accordance with international industry practices and regulations (ISO 13485, 21CFR820); to meet the objectives of the quality department, providing support in corrective and preventive actions (CAPAS) and implementing actions that generate defect reduction. Roles & Responsibilities: * Focused on transitioning new products to the Mexicali site * Use Personal Protective Equipment. * Participates in the emergency brigades and Health and Safety commission, when required. * Use devices, accessories, tools, and equipment according to the process; verifying that they are in good conditions of use and reporting those that are in poor condition for repair. * Communicates unsafe acts or conditions to their superiors. * Participates in the Health and Safety courses established by the Company. * Maintains order and cleanlin
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