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Quality Systems Engineer-CSV Specialist

Req ID: J2329477-IL

  • Ubicación
    Clinton, MA, Massachusetts, United States of America
  • Categoría Grupo de Calidad
  • Publicado miércoles, 27 de julio de 2022
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

Descripción del Trabajo

SUMMARY
Function as an administrator for QMS and training software systems at the site. Manage and Maintain QMS/LMS systems to comply with applicable regulatory and customer requirements. Establish and maintain CSV requirements for software systems used at the site.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
    Develop and maintain procedures/documents for software validation activities
    Maintain master software application listing which identifies the software used by site
    Lead periodic review process of user access list for software systems used at site
    Coordinate with IT when hardware/software upgrades/updates are needed.
    Assist users with software validation activities.
    Develop to be a computer software validation SME for the site
    Develop to be a data integrity SME for the site
    Site Admin for QMS/LMS software systems
    Approve/Review/Author documents such as User Requirement Specifications, Validation Plans, Risk Assessments, Test Protocols/Reports, Validation Summary reports 
    Ensure complaints use of Change Notices for documentation submission/changes
    Participate in problem-solving and process improvement activities.
    Support all programs and initiatives related to the Jabil Healthcare Ethics code, Values and Sustainability programs.
    Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position 



MINIMUM REQUIREMENTS
Bachelor's degree preferred; or equivalent combination of education and experience.

3-5 years of medical device or pharmaceutical industry experience. Knowledge of ISO 13485 and FDA part 820.
Excellent attention to detail, follow through and organizational skills
Must be self-motivated and able to work independently with minimal supervision/guidance
Demonstrated working knowledge of CSV practices and requirements in a regulated medical device manufacturing environment (21 CFR Part 820,21 CFR Part 11, ISO 13485, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP),etc)

 

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