Company Description At Intuitive, we are united behind our mission: 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.

　　As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

　　Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

　　Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world 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 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 advance the world of minimally invasive care. Job DescriptionPrimary Function of Position:

　　The Global Corporate Auditor will support the execution of an efficient and effective internal audit program. They will support the internal and external audit program to ensure compliance to the regulatory requirements and standards of the Quality Management System (QMS). This individual will have a clear understanding of applicable laws and regulations in order to identify and manage the company's risks appropriately. They will use Quality Auditing principles, tools and techniques to support quality systems and processes aligned with the overall Company strategy and mission affecting continuous process improvement. They will ensure effective closure of audit findings, by working with cross functional and varying level of departments/business partners to ensure comprehension, development, and execution of corrective/preventive action and evaluation of effectiveness checks. They will assist with gap assessments including working with functional area owners to close regulatory gaps. They will continually educate the organization on effective compliance systems, processes in alignment with applicable laws and regulations. They will support the quality and regulatory improvement projects and provide insight for long-term strategic QMS improvement.

　　Roles and Responsibilities:Conduct internal audits across all sites. May also coordinate internal audits and provide oversight to external contractors.Support external audits or regulatory inspections across global sitesComplete gap assessment for regulations, regulatory standards, and corporate proceduresTrain company employees on Quality System Regulations and quality system foundational principlesWork together with strategic partners across global sites to assure compliance with all company procedures and regulatory requirements.Support Quality System projects for new and changing regulatory requirementsServes as the lead coach/consultant to educate internal customers on regulatory compliance processes and regulationsCreate, approve, and maintain company quality documents, such as quality procedures, work instructions, and formsSupport CAPA program as audit findings are an input to the CAPA process. Review, approve, provide feedback on CAPA documentation as assignedAnalyzes quality data and provides compliant, pragmatic guidance to support Regulatory Compliance activities including responses to agency requests for information and analyses to support qual ty improvement projects.Prepare responses to regulatory audit observations. Ensure that responses are clear, comprehensive, accurate, and well written to mitigate potential for further regulatory actions.Provide data to support; Risk based audit schedule, process analysis, process controls, FDA trending and finding history, and needed process improvements activitiesSupport implementation and continuous improvement of the audit programs, auditor qualification programs, and company-wide inspection readiness.Support, consult, train, and lead quality improvement projectsProvide Quality System ConsultationSupport new site integration activities across global sitesAssist in the development of Quality System Metrics and KPIsQualificationsSkills, Experience, Education, and Training:Minimum Bachelor of Science degree in Technical, Engineering or Science related field.ISO certified lead auditor (ISO 9001, ISO 13485 and/or ISO 14155 or ASQ CQA)Minimum 2 years of FDA /ISO 13485 lead auditing experience,Minimum 7 years' of experience in quality in the medical device or pharmaceutical industryExperience as a Quality Engineer, Software and Validation experience is an assetStrong knowledge of EU-MDR, ISO 13485:2016; Medical Device Single Audit (MDSAP), and 21 CFR 820 requirements, familiarity with EU-MDR, , Health Canada, and other international regulatory requirementsPrevious front room experience participating in notified body and FDA inspectionsFamiliarity with GMPs related to Combination and Drug ProductsAbility to work on virtual teams, remote management; self-directedAbility to be a team player...

　　Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity