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Senior Quality Engineer

1 month ago

Indiana, United States Intuitive Full time

Job Description Primary Function of Position The Senior Quality Engineer supports product development from concept through commercialization and will serve as the core team member for the cross-functional product development team. Senior Quality engineer will provide expertise and guidance to the team on design control and risk management, Design for Reliability and Manufacturing, product Development Life Cycle, and Process Validation. In addition, this position will play an effective role to ensure that the developed products meet quality standards consistent with Intuitive’ s quality processes, while meeting all external design control and regulatory requirements. Essential Job Duties Engage and manage multi-level and multi-discipline project work teams Develops and implement projects to achieve targets and tracks progress against schedules; and communicates status to management Provide support and expertise in the implementation and enforcement of GMP, ISO and FDA requirements Proficiency with pFMEAs, Test Method Validations, Root Cause, CAPAs, Non-Conformance Management, and Process Validation Proficiency with advanced data analysis tools and statistical methods (i.e., ANOVA, DOE, etc.) Provide statistical support and analytical problem solving for manufacturing, technical services, and product development to identify root cause of problems Experience with computerized systems, such as SAP, Trackwise, Agile, etc. Experience in product design changes, manufacturing changes, supplier changes and the associated requirements to execute such changes Outstanding organizational, communication, presentation, and interpersonal skill Solid contributor to the planning and execution of design controls, risk management, and design verification/validation for new products Ensure reliable and scalable Designs to transferred to manufacturing by supporting Design for Reliability and Manufacturing activities. Support Regulatory Affairs with creating submissions and responding to submission questions. Support internal and external audits, including preparation and direct interaction with auditors. #J-18808-Ljbffr