Detalle de la Oferta

Descripción de la Oferta

- Administrate the Validation Master Plan for Validations and Revalidations.
- Assure that the requirements from ISO 13485, QSR Part 820 and 11 related with control of Softwares and Validation Master Plan for Software are properly followed.
- Maintain the Plant Validation Master Plan for Software's and the templates for protocol reports in the System.
- Perform the annual review to the Plant Validation Master Plan for Softwares.
- Follow the Risk Analysis program for Software Validations.
- Perform training in Validation requirements under a regulated environment following CFR Part 820, 11, ISO 13485 and GAMP 5.
- Leader for CAPA's related to the Software Validation.
- Perform and give support in the test scripts creation.
- 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.
- May provide direction and mentoring to less experienced Software Validations Engineers.
- Demonstrated competence in Software Validation Quality Engineering body of knowledge.
- Writes, reviews, approves process validations/qualifications related to Software Validations in accordance with Jabil and customer requirements.
- Give support in the Audits from 1st, 2nd, 3rd parties.
- 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.