EMPRESA MAQUILADORA IMPORTANTE

Solicita: Quality Systems Specialist

• Descripción y Requisitos

  Descripción:

  The Quality Systems Specialist is responsible for performing quality systems duties including maintenance of Nonconformance process, planned deviation process among others. And to ensure that the document control is done in accordance with the requirements.
  
  Responsibilities and Essential Functions:
  

  • Ensures all quality documents fulfill the applicable requirements.
  • Maintains quality records on product testing, nonconformance in an accurate and timely manner.
  • Ensures documents are approved and distributed as intended.
  • Ensures that document changes are controlled, approved and distributed.
  • Ensures that all distributed documents are identified and in the latest version.
  • Ensures compliance of the Change Control process.
  • Provide Agile Training in Change Control for MX site.
  • Provide support for the compliance of the NCR, and Planned Deviation processes.
  • Serves as site trainer for the NCR and Planned Deviation processes.
  • Participate in quality projects with cross functional teams.
  • Facilitate the tracking and closure of local Nonconformances (NCs) to ensure 
  • Consistency in compliance in areas of evaluation, risk, corrections, timeliness, quality, and thoroughness of contest. 
  • Facilitate quality metrics gathering, analyzing, and reporting on a regular basis. 
  • Report on the performance of the Nonconformance process for review and as a basis for improvement.           
  • Conducts investigations, collects data, analyzes trends and prepares reports for a assigned quality processes             
  • Assists in the development, implementation, and review of standard operating procedures
  • Knows and follows all procedures and SOPs that apply to one's job.
  • Provide support in external audits as needed.

  Qualifications / Education:
  

  • Technical degree in a related field (bachelor's degree  preferably).
  • 2 years of experience or more working in the medical device industry.
  • PLM system/change management knowledge.
  • Knowledge on Root Cause Investigations tools.
  • Knowledge on non-conformance processes.
  • Must be able to speak, read, write, and understand English.

  
  

  
  

  
  

  Puesto: Calidad

• Información Adicional

  Tipo de contrato: Permanente
  Salario: Negociable

  Pais:MEXICO
  Estado o Region: Chihuahua
  Ciudad: Ciudad Juarez