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Software Validation Engineer II

Req ID: J2335263-IL

  • Ubicación
    Santo Domingo, Santo Domingo, Dominican Republic
  • Categoría Grupo de Calidad
  • Publicado lunes, 12 de septiembre de 2022
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

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.

Descripción del Trabajo

SUMMARY
To manage and execute the applicable validations of the computerized Systems. Follow the Validation Master Plan including procedures, validation templates and revalidations. Support the maintenance of the Software PLCs and Computerized Systems Inventory for the site, following the requirements in CFR Part 820 and 11.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Support to maintain the Validation Master Plan for Validations and Revalidations.
  • Assure that the requirements from ISO 13485, QSR Part 820 and 11 related with control of Software and Validation Master Plan for Software are properly followed.
  • Demonstrated competence in Software Validation Quality Engineering body of knowledge.
  • Writes, reviews, approves process validations/qualifications related to Software Validations in accordance with Jabil Healthcare and customer requirements.
  • Support maintenance the site Validation Master Plan for Software and the templates for protocol reports in the System.
  • SME for SAP and QMS/PLM systems.
  • Follow the Risk Analysis program for Software Validations.
  • Support to CAPA’s, NCMRs and complaints related to the Software Validation.
  • Perform and give support in the test scripts creation.
  • Supports audits of quality systems for deficiency identification and correction.
  • Assists in the process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 9001 and ISO 13485), Jabil Advance Problem Solving methods, and that documentation is complete and compliant with requirements.
  • Provide support in the Audits from 1st, 2nd, 3th parties.
  • Be part of the Internal Audit Team.
  • Support all company safety and quality programs and initiatives.
  • May perform other duties and responsibilities as assigned.
  • Provide support to all Safety, Health and Environment (EHS) programs and initiatives in order to support our zero-accident culture.


MINIMUM REQUIREMENTS

  • BS degree or equivalent in Industrial Engineer or Technologies Information career preferred
  • Minimum 1+ year work experience in a Medical Devices.
  • Or an equivalent combination of education, training or experience.
  • Good English Knowledge

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.

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 your local police department. Any scam job listings should be reported to whatever website it was posted in.

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