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    Quality Engineer - Irvine, United States - Baxter Healthcare Corporation

    Baxter Healthcare Corporation
    Baxter Healthcare Corporation Irvine, United States

    2 weeks ago

    Default job background
    Description
    This is where you save and sustain lives
    At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world.

    You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

    Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
    Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
    Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
    Your Role at Baxter

    Responsible for providing technical support and service for all aspects of quality engineering while ensuring compliance to safety standards and global regulatory requirements.

    This includes, but is not limited to reviewing non-conformances, complaints, defect reports, and audit findings to coordinate corrective action.

    In addition to providing technical support and service to the Irvine facility, the following functions may also be performed:
    change control, training, data integrity, defining, initiating, specifying, documenting, and training.
    What you'll be doing
    Apply sound engineering practices and problem-solving methodology (e.g. Lean & Six Sigma) to arrive at robust and practical solutions in an expedited manner.


    Act independently with minimal supervision to investigate and analyze process or product issues and design improvement suggestions based on recent technical knowledge.

    Perform root cause investigation analysis and document within the quality system as appropriate (NCR/CAPA).

    Design and perform routine testing, project experiments, analysis of data and reports results.

    Perform engineering studies on new equipment to determine proper settings, control points, etc. including data gathering during start up and test batches.

    Work with manufacturing and other functional groups on manufacturing regulatory compliance issues.

    Write, execute, and develop report for validation activities, including qualification protocols.

    Participate in continuous improvement projects.

    Perform work assignments within production department that include training, technical support and/or process trouble shooting support.

    Perform other duties as assigned.

    What you'll bring
    Bachelor's degree in engineering years of experience.

    Understanding of engineering principles in various engineering disciplines related to medical device manufacturing.

    Demonstrated ability to effectively run projects and direct the activities associated with those systems in regulated environment.

    Strong command of problem-solving techniques and ability to coach others in their application.

    Must be able to write clearly and informatively, present numerical data effectively, able to read and interpret written information.

    Must have strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills.

    Ability to work collaboratively in a team-oriented environment.

    Working knowledge of FDA quality system regulations.

    Working knowledge of Quality Management System.

    We understand compensation is an important factor as you consider the next step in your career.

    At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

    The estimated base salary for this position is $72,000 - $99,000 annually. The estimated range is meant to reflect an anticipated salary range for the position.

    We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change.

    Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

    For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

    #LI-KV1

    The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

    Equal Employment Opportunity
    Baxter is an equal opportunity employer.

    Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

    EEO is the Law
    EEO is the law - Poster Supplement
    Pay Transparency Policy
    Reasonable Accommodations

    Baxter 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.
    Recruitment Fraud Notice


    Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter 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 .
    Armstrong Ave Bldg 3|Irvine, CA 92614|United States of America
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