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Elmira

    Senior Quality Systems Engineer - Elmira, United States - Jabil Circuit, Inc.

    Jabil Circuit, Inc.
    Jabil Circuit, Inc. Elmira, United States

    2 weeks ago

    Default job background
    Description
    Jabil is seeking a Senior Quality Systems Engineer to work for the Elmira, NY location. The Senior Quality Systems Engineer will have the responsibility and authority to lead assigned Quality System processes.

    The qualified candidate will also lead internal audits, customer audits, ISO Registration audits, and FDA Inspections and when required prepare submissions and responses to FDA and ISO Registrars.

    Potential travel up to 10% throughout the year.

    Competitive Salary and Benefits Offered


    ESSENTIAL DUTIES AND RESPONSIBILITIES
    Leading internal audits and supplier audits.

    Leading the readiness program for ISO Registration audits, FDA Inspections, and customer audits.

    Preparing submissions and responses to FDA and ISO Registrars.

    Acting as the primary compliance contact for site departments, business units, and corporate functions.

    Acting as a subject matter expert for the Quality Systems and Compliance programs.

    Ensuring the site's quality system development, effective maintenance, and continued compliance with business unit requirements, medical device regulations, and standards (i.e., U.S. – FDA, ISO 13485, Anvisa).


    Supporting the effectiveness of the Quality Systems and Compliance programs by working collaboratively with other stakeholders to ensure effective and compliant processes.


    Performing all duties in alignment with the Jabil Corporate Code of Ethics, Corporate and Global policies, Employment Labor Laws, Health Regulatory Agency Regulations, and Safety Requirements.

    May perform other duties and responsibilities as assigned.


    MINIMUM QUALIFICATIONS
    Bachelor's degree required in Regulatory Affairs, Engineering, Business, or similar related degree
    ORMaster's degree is preferred.

    At least 8 years of industry experience within Quality and/or Regulatory


    OR
    a combination of education, experience, and/or training.

    Experience leading and managing high-performing teams.

    Knowledge of the U.S. and international medical device quality system regulations, standards, and best practices (21 CFR 820, ISO

    Experience with compliance assessments, gap assessments, and risk assessments.

    Experience with program change management practices, Lean or Six Sigma programs, and system integration efforts.


    BENEFITS WITH JABIL
    Along with growth, stability, and the opportunity to be challenged, Jabil offers a competitive benefits package that includes:
    Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options

    401K match

    Employee Stock Purchase Plan

    Paid Time Off

    Tuition Reimbursement

    Life, AD&D, and Disability Insurance

    Commuter Benefits

    Employee Assistance Program

    Pet Insurance

    Adoption Assistance

    Annual Merit Increases

    Community Volunteer Opportunities

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