Principal Specialist

Vantive 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 Vantive

Global 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 doing

• Serve 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 policies

• Understands 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 workshops

• Devises new approaches to complex problems through adaptations and modifications of standard technical principles

• Perform all other duties and responsibilities as determined by supervision/management.

What you'll bring

• B.S. in Engineering Degree or related field

• 5 - 8 years of Quality Assurance or Pharmaceutical Industry or Medical Device experience

• Experience working with and facilitating multifunctional, global teams including diversified cross functional team across clinical, plant and design center locations

• Thorough knowledge of applicable procedures, specifications, regulations and standards.

• Good verbal and written communication skills

• Strong 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.

Advanced Molding and Extrusion techniques (Learning / Doing (1)), Automation, reliability & smart manufacturing (Applying / Overseeing (2)), Critical Systems (Applying / Overseeing (2)), Data Analysis & Analytics (Applying / Overseeing (2)), Digitalization & Systems Engineering (Applying / Overseeing (2)), First Principles Thinking (Applying / Overseeing (2)), Lean & six sigma process knowledge (Applying / Overseeing (2)), Machine Learning & Artificial Intelligence (Not Applicable (0)), Manufacturing & Process Knowledge (Applying / Overseeing (2)), Modeling & Simulation (Leading / Driving (4)), Operational Quality Assurance (Applying / Overseeing (2)), Process Automation (Applying / Overseeing (2)), Product / Project Management (Applying / Overseeing (2)), Smart Operations / Industry 4.0 (Learning / Doing (1)), Software Integration (API, Data Pipelines) (Not Applicable (0))

Reasonable Accommodation

Vantive 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 click on the link here and let us know the nature of your request along with your contact information. Form Link

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