Saltar al contenido principal
Volver a la búsqueda

Sr Quality Assurance Manager

Req ID: J2267222

  • Ubicación
    Chihuahua, Chihuahua, Mexico
  • Categoría Grupo de Calidad
  • Publicado jueves, 8 de abril de 2021
  • Tipo Tiempo completo

Descripción del Trabajo

Manages through subordinates, the development and maintenance of quality evaluation, control systems and protocols for processing materials into partially finished or finished products for a business unit or corporate. Manages the audits of quality systems for deficiency identification and correction. Manages the overall development of inspection and testing processes, mechanisms and equipment as applied to new or existing products. Conducts quality assurance testing as appropriate.

Ensure that all departments and suppliers are adhered to the Quality System requirements and regulations enforced by the US(FDA) Food and Drug Administration, COFEPRIS, ANVISA, Japanese Medical Ordinance and ISO13485. Manages and coordinates the implementation of Quality System programs designed to ensure continuous production of products consistent with established standards and/or customer specifications by performing the following duties personally or through subordinate supervisors. Plan, implements and directs the Quality System program of Healthcare Chihuahua manufacturing facility, through failure investigation reporting, corrective action initiation and tracking and monitoring the effectiveness of changes.

· Provides input to and support of plant and company safety initiatives

· Is the Quality System Management Representative for Jabil Healthcare Chihuahua facility during FDA, ISO and customer assessments, aswell as the scheduled management review meetings
· Manages the development, modification and maintenance of all quality evaluation and control systems in areas of product responsibility, and in compliance with company policies, customer requirements and government regulations.
· Manages and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
· Manages statistical analysis projects to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
· Manages the auditing process of quality systems for deficiency identification and correction, and ensures that corrective action plans are put into place and executed in a timely manner.
· Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with all, customer and regulatory requirements
· Manages the development of sustainable, repeatable and quantifiable business process improvements. Reports to management as necessary and required on the status of quality assurance programs and practices.
· Manages compliance all site required agency certifications related to product and process quality. ISO 9001, ISO 13485, ISO 14000, IATF 16949.
· Manages up front quality planning for new products to ensure appropriate quality systems and processes required to support the introduction are developed and implemented.
· Exchange knowledge and information with other Jabil facilities to ensure best practices are shared throughout the Jabil organization.
· Generate and maintain applicable quality system documentation, as needed. Documents such as Device Master Record (DMR), Device History File (DHR), validation protocols, for example, and other specified documents in support of customer projects.
· Ensure conformity of initial and ongoing validations performed in support of the GMP quality systems.

· Meet corporate, local, departmental and individual objectives.

· 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.
· May perform other duties and responsibilities as assigned.


· Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
· Domain in ISO13485, CFR 21 Part 820, NOM 241,MHLW Ministerial Ordinance No. 169, ANVISA, EU MD

· Experience with process validation IQ, OQ, PQ, GRR (test method validations)
· Experience in root cause analysis, Six Sigma methodology, CAPA system

· Leadership skills, Build trust relationships, Decisive, Resilience, Agility, Develops himself and others

· The proven experience to manage a large, diverse department and ability to handle multiple priorities at a given time.

· Ability to effectively prioritize activities based on identified needs for improvement of the CUU manufacturing Quality System

· Bilingual (Spanish and English)

· Bachelor’s degree required. Master’s degree preferred. Preferred Engineering or Technology disciplines.
· Minimum ten (10) years of experience and required industry experience
· Or a combination of education, experience and/or training.

· ASQ certifications are recommended

Image 17 (1)

¿No estás listo para aplicar? ¡Únase a la red profesional de Jabil!

Más información sobre las próximas oportunidades profesionales y eventos Jabil

Únete ahora