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    Design Quality Assurance Engineer - Austin, United States - Enovis

    Enovis
    Enovis Austin, United States

    1 week ago

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    Description

    Job Description:
    At EnovisTM we sweat the little things.

    We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence - with the goal of transforming medical technology as we know it.

    Because that's how we change the lives of patients for the better. And that's how we create better together.

    As a key member of the Quality Assurance team you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.


    Job Title:
    Quality Assurance Engineer - Design Quality Focus

    Reports To:
    Design Quality Engineering ManagerLocation:Austin, TX

    Business Unit Description:
    US SurgicalJob Title/

    High Level Position Summary:

    Utilizing a comprehensive knowledge of engineering and problem-solving principles, this position is responsible for a variety of complex activities regarding the design, implementation, and maintenance of quality assurance procedures and work instructions to ensure external safety, quality, and compliance with complex Company standards and government regulations.

    This position primarily supports New Product Development and Sustaining Product Development and serves as the QA representative on various PD initiatives.


    Key Responsibilities:
    Participating in design and manufacturing reviewsGenerating DFMEAs/UFMEAs and participating in risk analysis discussionsReviewing and approving design and development documentationServe as subject matter expert for design quality in ISO and FDA auditsAuthoring procedures and work instructions that define and govern the quality systemConduct internal audits of the quality system and other business functionsEvaluating nonconforming material and dispositioning based on cross-functional engineering reviewAssuring compliance to internal and external specifications and standards (i.e. GMP, ISO, FDA, MDD)

    Reviewing trends in device failures associated with customer complaints and nonconforming materialLeading and owning corrective and preventive actionsWorking on complex special projects as assignedMinimum Basic Qualifications:
    Bachelor's in Biomedical or Mechanical Engineering and 3+ years of experience.
    Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required; preferred knowledge of ISO13485 quality standards.
    Knowledge of technical writing quality and best practices.

    Required basic knowledge of manufacturing processes:
    key focus into metrology, precision machining, grinding, product cleaning, and sterilization.
    Individual should have knowledge of Microsoft Office Suite of software or equivalent.


    Travel Requirements:

    Up to 10%Desired Characteristics:

    Preferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM.Prefer CQE, Lean, or 6 Sigma Certification.

    Advanced knowledge of ISO 14971 and risk management principlesDetail oriented and analyticalPhysical Requirements:
    Ability to sit/stand for long periods of timeAbility to lift/carry/pull up to 25 lbs"Creating better together". It's the Enovis purpose, and it's what drives us and empowers us every day on a global scale.

    We know that the power to create better - for our customers, our team members, and our shareholders - begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

    Watch this short video and discover what creating better together means to us at Enovis:
    Our Enovis Purpose, Values and Behaviors on VimeoWe offer a comprehensive benefits package which includes:Medical InsuranceDental InsuranceVision InsuranceSpending and Savings Accounts401(k) PlanVacation, Sick Leave, and HolidaysIncome Protection PlansDiscounted Insurance RatesLegal ServicesABOUT ENOVISEnovis Corporation (


    NYSE:
    ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows.

    Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.

    Visit to learn more.


    EQUAL EMPLOYMENT OPPORTUNITY:

    Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria and without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law.

    We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law.

    We value the unique contributions that every employee brings to their role with Enovis.

    ABOUT ENOVISTMEnovis Corporation (


    NYSE:
    ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows.

    Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.

    For more information about Enovis, please visit AA M/F/VET/Disability StatementAll qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.

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