BVI BEAVER VISITEC (INDUSTRIA MEDICA)
Solicita: Quality Assurance Engineer
    Descripción y Requisitos


EDUCATION & BUSINESS EXPERIENCE REQUIREMENTS

  • Minimum 3 to 5 years’ experience as a Quality Engineer in the medical device industry
  • BA/BS degree in science or other technical field.
  • Experience in starting and transferring operations abroad to Mexico.
  • Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485
  • Demonstrated skills in statistical analysis.
  • Individual must have a hands-on approach.
  • Experience participating in internal and external audits (e.g., FDA, Suppliers)
  • Strong organizational and time management skills.
  • Experience with CAPA, complaint investigation, field action processes and risk management.
  • CQE, CQA preferred

REQUIRED COMPETENCIES:

  • Recognized as a technical leader within the company and engenders trust when working with customers or suppliers
  • Capable of leading a Continuous Improvement Team, CAPA team, or working with a customer or supplier to resolve product quality issues
  • Works effectively on cross functional teams to establish appropriate processes pertaining to quality Communication
  • Excellent written and oral communication skills
  • Ability to formulate responses to common inquiries or complaints from customers and regulatory agencies
  • Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports; and give oral presentations

DEEscrituraION OF RESPONSIBILITIES

The Quality Engineer is responsible for reviewing and analyzing complaint data, performing root-cause investigations to establish corrective action plans and implement corrective actions, developing and performing test methods for product testing and investigations, writing and updating procedures as required to ensure the quality system is compliant with regulations including the FDA Quality System Requirements (QSR), ISO 13485, Canadian Medical Device Regulations (CMDR), and the Medical Devices Directive (MDD). 

Puesto:  Ingeniero - Calidad
    Información Adicional
Tipo de contrato: Permanente
Salario:  Negociable

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

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