Principal Specialist

OverviewVantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere.
For 70 years, our team has driven meaningful innovations in kidney care.
As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies.
Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre.
Each of us is driven to help improve patients' lives worldwide.
Join us in advancing our mission to extend lives and expand possibilities.Your Role at VantiveGlobal Quality Operations and Strategy Organization manages global initiatives within the Process and Production Element.
Employee must apply a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products or processes.
Employee must have skills in planning, executing, and functionally directing important engineering assignments, which require independent judgement.What you\'ll be doingServe as the technical expert within a department in the Quality organization with responsibility for results in terms of production and process controls.Implements the quality systems procedures for production and process controls and manages compliance to the global policiesUnderstands and assures conformance to regulations.
Interfaces with regulators during regulatory inspections.May participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.Interacts frequently with leaders and functional peer group of technical experts.Identifies and leads continuous improvement projects with the objective of achieving quality, reliability and cost improvements.Facilitate Cross-functional workshopsDevises new approaches to complex problems through adaptations and modifications of standard technical principlesPerform all other duties and responsibilities as determined by supervision/management.What you\'ll bringB.S.
in Engineering Degree or related field5 - 8 years of Quality Assurance or Pharmaceutical Industry or Medical Device experienceExperience working with and facilitating multifunctional, global teams including diversified cross functional team across clinical, plant and design center locationsThorough knowledge of applicable procedures, specifications, regulations and standards.Good verbal and written communication skillsStrong analytical and problem solving skills.Ability to mentor a team of employees.Good communication and leadership skills.Good interpersonal/communication/influencing/negotiation skills.Good project management skills.Reasonable AccommodationVantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request along with your contact information.
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