Senior Manager Continuous Improvement Quality Engineering

At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Our mission is our guiding force; our culture is the DNA that makes us unique. As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare's complex challenges. We believe a great idea can come from anywhere-inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and strive to achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's help to advance the world of minimally invasive care. The Sr. Manager, Continuous Improvement Quality Engineering (CIQE), manages the CIQE and CSV team members and associated responsibilities. This includes management and oversight of the escalation, CAPA processes, and Computer Software Validation processes including fulfilling CAPA Manager duties. Roles & Responsibilities: * Developing strategies and hands-on execution of continuous improvement programs that strongly align with Intuitive Surgical standards and customer needs while meeting all applicable Medical Device Regulations. * Manage a team of high performing Continuous Improvement Quality Engineers and Computer Software Validation Engineers. * Provide oversight for the overall management and effectiveness of the CAPA program and CSV in addition to supporting other cross Intuitive Surgical improvement initiatives. * Evolve existing processes/systems to ensure timely escalation identification of product quality & compliance issues within a closed loop quality system * Define opportunities for their team, analyze data, contribute to overall quality system harmonization and integration related business processes all while developing high quality Continuous Improvement Quality Engineers to support these initiatives. * Develop and implement measures to monitor the effectiveness of the team, the CAPA system, continuous improvement programs and other applicable areas of importance to the Intuitive Surgical business and the quality management system. * Evolve existing processes/systems to ensure compliance and timely execution of Computer Software Validation requirements. * Provide support to external and internal audits related to computerized system validation activities. * Solid knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, GAMP5. * Ensuring alignment of processes, procedures and methods across multiple organizations (internal and external). * Ensuring systems are fully implemented and integrated with other quality management systems, site and global functions. * Authoring and /or revising SOPs. * Ability to provide guidance on revising validation documents and protocols. * Ensure projects related to CSV activities are manage to meet project timelines * Development, execution and approval of change records. Skills, Experience, Education, & Training: * Engineering/technical degree and a minimum of 7 years of related experience in Engineering, Operations, Quality Systems, or a continuous improvement environment is required. At least 4years in a management or supervisory position * Strong interpersonal and communication skills: * Passionate about our mission to constantly make our products and processes better * Able to assist in finding creative solutions around constraints. * Thorough knowledge of quality management and CSV (GMP, 21CFR Part 11, GAMP) aspects of computer system applications. * Good knowledge of global regulatory requirements related to computer software validation * Experience in completing validation of ERP (SAP), EQMS systems, and COTS application. * Experience in validation digital solution systems a plus. * Experience in CAPA program implementation, including regulatory requirements and industry-standard best practices * Experience in process validation, equipment validation, software validation, and/or computer software validation. * Knowledge of Quality System requirements to determine GXP relevance for automated systems. * Knowledge of Process improvement tools and methodologies (Lean, Six Sigma) is required. Green or Black Belt Certification in Lean or Six Sigma is preferred * Experience gathering/processing internal and external customer needs * Strategic mindset with strong leadership and influencing skills * Business Acumen - has demonstrated business knowledge and ability to display the linkage between projects and desired business results * Proven ability to develop and coach engineers at various experience levels * The ability to collaborate effectively with senior level management in a cross-functional team environment is required * Technical Aptitude - required to collect and analyze data for determining an improvement strategy * Team Player and Leader - demonstrated ability to lead, contribute to teams, and understand team dynamics * Strong decision making and negotiating skills. Must possess the ability to connect the details to the bigger picture * Ability to manage multiple projects/deadlines with changing priorities. 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 Employment 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. * Shift : * Shift 1 - Day * Travel : * Yes, 10 % of the Time Travel Requirements: Yes, 10 % of the Time Shift: Shift 1 - Day