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    Job · 22460191

    Vantive logo

    Principal Eng, Quality Assurance

    Vantive · Bengaluru · onsite · Posted 1d ago

    Undisclosed8–10 yrsfulltimeSourced fromNaukri

    About a minute. You'll make an account on the way through.

    About this role

    Job Summary
    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.
    Education and/or Experience
    BS Degree (engineering, science or pharmaceutical related discipline) with 8-10 years of experience in medical device industry.
    Experience in the design and development of electromechanical devices is required.
    Qualifications
    • Demonstrated compliance knowledge in the areas of medical device and drug product development, change control, NCR CAPA, and risk management.
    • Strong verbal and written communication skills
    • Strong interpersonal / communication / influencing / negotiation skills required.
    • Demonstrated leadership, teaming, and communication skills accomplishing success with large teams.
    • Device regulation (design control) experience required
    • Knowledge of FDA (21 CFR Part 210, 211, 820, 803, 806), ISO 13485, ISO 14971, IEC 60601, and standards for medical devices and therapeutics.
    • Strong analytical and problems solving skills utilizing DMAIC tools, Six Sigma Engineering, ASQ or other certifications desirable.
    • Proficient with Minitab or any equivalent statistical tool is required.
    • Proficient in product and process change controls and risk management
    • Apply DMAIC and statistical techniques to address issues and investigations
    • Demonstrates ability to work independently
    Essential Duties and Responsibilities
    • Provides quality guidance and approval to product design and process change controls to ensure compliance to the required Product Development Process (PDP) deliverables, resulting in the development and sustaining of safe and effective medical devices
    • Responsible for Quality Assurance of the Product Development and Lifecycle Management process.
    • Supports product verification testing to ensure product reliability and conformance to specifications
    • Organize and implement site support of corporate audits and Notified Body regulatory inspections. Act as front room lead for audits and inspections.
    • Educates and trains on product body of knowledge and Vantive QMS principles
    • Analyzes data from various sources (Non-Conformances, Field Corrective Actions, Medical Device Reports, and Complaints) to drive decisions
    • Drive Quality culture mindset and provide input for code quality improvements.
    • Identify and oversee specific process product improvement initiatives such as test case adequacy, requirement levelling and test automations.
    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 indicate your request and contact information. Form Link
    Recruitment Fraud Notice
    Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.


    Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

    Sourced from naukri

    Skills

    Product DesignCfrDialysisISO 13485code qualityNegotiation SkillsbsauditsCAPAChange ControlElectromechanicalDmaicMinitabDigital SolutionsMedical DevicesCommunication SkillsAdministrationcompliancePharmaceutical

    About Vantive

    Vantive logo

    Vantive

    Healthcare

    939

    employees

    2025

    1 years old

    Bangalore / Bengaluru, Karnataka

    India

    ₹27.3L PA avg

    Avg at Vantive

    About

    The work to support vital organs takes many forms — from clinicians fighting to save lives in the intensive care unit to patients undertaking their dialysis journey.

    Industries

    Healthcare

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