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Quality System Engineer

Company: Jabil
Location: Asheville
Posted on: May 28, 2023

Job Description:

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world's leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.
SUMMARY In partnership with the site Quality Assurance Manager, carry out the Quality Management System function for the site. Accountable and responsible for ensuring best practices pertaining to the use of quality tools are developed and deployed at the site. This position is audit facing and provides a high level of internal and external interface with colleagues, customers, and regulatory agencies. Executes major quality initiatives / projects at the direction of the site Quality Assurance Manager. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.



  • Identifies and manages performance through daily, weekly, monthly metrics, with clear stakeholder communication and issues elevation.


  • Applies systematic technical problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues in documentation and quality system. --- Identifies, plans, and executes quality requirements resulting from internal and external changes.


  • Uses the Quality Management System (QMS) in developing and executing the appropriate processes for consistent, technical, risk-based decision making and continuous improvement efforts.


  • Leads the daily management and operations of the company document control system (including the creation and release of documents, drawings, and changes through the change control process).


  • Develop and maintain the organization's QMS IT solution (e.g. NWQS, PTC Windchill, etc.).


  • Develop and implement policies, procedures, work instructions, and forms in conjunction with functional managers and technical staff.


  • Maintain and retain quality records in accordance with procedures.


  • Develop and implement procedures, work instructions and/or knowledge/job aids to assess and support performance improvement, learning and development programs.


  • Interfaces with internal functional stakeholders (e.g. manufacturing, engineering, work cell, supply chain, etc.) to ensure internal and customer requirements are consistently met


  • Ensure compliance of project activities to appropriate standards and regulations (FDA, ISO, etc.).


  • Ensure corrective actions are documented, implemented, verified effective, and submitted on time.


  • Support all company safety and quality programs and initiatives.


  • Perform other duties and responsibilities, as assigned.


    KNOWLEDGE REQUIREMENTS


    • Experience creating & implementing policies, procedures, and work instructions in support of a Quality Management System.


    • Experience developing and delivering training to individuals and groups of employees.


    • Experience with internal and external quality audits and inspections.


    • Able to assess and recommend continuous improvement efforts to QMS.


    • Knowledge of Quality Management System, 21 CFR Part 820 & ISO 13485.


    • Device History Record experience.


    • Must be able to interact with management team and regulatory bodies in a professional manner both orally and in written communication.


    • Excellent problem-solving abilities.


    • Strong computer skills. Proficiency in use of personal computers, Microsoft Office products (Excel, Word, and PowerPoint) and e-mail skills required.


    • Frequent sitting, standing, and walking with occasional lifting of up to 25 lbs.


      MINIMUM REQUIREMENTS


      • Bachelor's degree preferred with a minimum of 5 years related experience, or an equivalent combination of education and experience.


      • Lead auditor certification preferred


        BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver's license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact the Federal Bureau of Investigations internet crime hotline (www.ic3.gov), the Federal Trade Commission identity theft hotline (www.identitytheft.gov) and/or your local police department. Any scam job listings should be reported to whatever website it was posted in.
        Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.
        Accessibility Accommodation
        If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address.

Keywords: Jabil, Asheville , Quality System Engineer, Other , Asheville, North Carolina

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