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Job Details Israel

QMS Specialist (09e3f248c67f)

Israel Jobs

Israel Jobs



Haifa, Haifa, Israel

Description - ExternalJoining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority. Intuitive Israel is focused on our digital products development. The fast-growing R&D center in Haifa and Tel-Aviv is leading advanced technological development in the minimal invasive space. We leverage data to provide digital capabilities to clinicians to improve the clinical workflow and the procedure outcomes. The Israeli team’s deliverables are impacting patient’s lives worldwide on a daily basisIntuitive 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.Primary Function of Position:We are seeking a QMS (Quality Management System) Specialist to ensure overall compliance of internal procedures to regulatory requirements and standards. The QMS Specialist will be responsible for maintaining the company's QMS. In addition, the QMS Specialist will support systems and processes that are aligned with the overall Company strategy and mission affecting continuous process improvement. The QMS Specialist will provide solutions and processes that support scalability and compliance to regulatory requirements.Qualifications - ExternalRoles and Responsibilities:Manage the QMS –entire documents and records systemEnsure compliance of the technical dossier (including Design History File and Device Master Record) with current documentsCreate, update, and/or review QMS related documents, in collaboration with process ownersExecute QMS-related annual plans: internal audits, supplier audits, training, and management review. Follow-up on the associated action itemsHandle quality events: CAPAs, non-conformities and customer complaintsIssue reports and analyze data for management review and other purposesWork on special projects with regards to organization’s orientationEnsure corrective and preventive actions are issued, implemented, verified, and closed within set timeframesPrepare the company to regulatory authorities and suppliers audits. Providing training sessions to the company's employees – optionalAuthorityAdministrator of the QMS SWTaking responsibility on execution of the annual plan in the quality management field and on proper handling of quality events.Required Knowledge, Skills, and Experience:College degree2-4 years of practical experience with Quality Management Systems from medical devices or pharma companiesKnowledge of international standards and regulatory guidelines (at least one): ISO 13485 / ISO 27001 / CFR part 820 / CFR part 210 / CFR part 11 / ISO 62304.Experience in R&D activities, design control in particular.Experience in software medical products – an advantage.Strong communication skills in English (both oral and written).Capacity to work both independently and in a team-oriented environment. Part of the work will be done remotelyGood interpersonal skills and the ability to work as part of a team.Attention to details, combined with goal-orientation.Computer applications proficiency, Tech-savvyGood organizational skillsPreferred SkillsScientific / technological college educationInternal audits qualificationCareer experience from medical devices companies, rather from quality rolesAdditional NotesComfortable working a flexible dynamic schedule, including meetings with US Shift : Shift 1 - Day Travel : NoTravel Requirements:No Shift:Shift 1 - Day