Quasar Medical Tecate S.A. de C.V.

Manufacturing Engineer II

Quasar Medical Tecate S.A. de C.V.

Tecate, Baja California

Hace 15 horas

Compartir:

Corporativo

Giro

Maquiladora (Export.)

Actividad principal

Manufactura de dispositivos médicos.

Número de empleados

100

Sitio Web corporativo

Datos de sucursal

Los Olivos No. 6500 Int-1D, Modulo 3 Parque Industrial El Bajio Tecate, Baja California

Descripción y detalle de las actividades

The key responsibilities and /or task of the Manufacturing Engineer II consist of transfer projects (new process and/or products), improving the current manufacturing process (yield, productivity and on time delivery), and support to Operations activities.

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Follow all Good Manufacturing Practices and SOPs as defined by the Company’s polices ensuring that FDA and Quality Standards are met.
  • Responsible for executing transfer projects.
  • Leads and coordinates a cross functional team (supply chain, quality, and manufacturing departments) to define clear goals and objectives as well as set the appropriate conditions for each transfer project. 
  • Prepare and write technical reports and technical data such as validation protocols, qualification test procedures, acceptance test procedures, reports, component maintenance manuals, etc.
  • Creating/updating work instructions as well as translation of these documents as needed within the Company’s Quality System requirements.
  • Key member of the continues improvement team applying; Theory of Constraints, Six Sigma, and Lean Manufacturing methodologies as tools to drive improvements in manufacturing costs, efficiencies, and lead-times.
  • Interact with manufacturing lead persons, supervisors and managers as needed to identify, and resolve/ improve
  • manufacturing deficiencies.
  • Responsible for managing and execution of EHS (Environmental, Health and Safety) projects and/or regulatory activities.
  • Establish and utilize project management tools to manage projects with appropriate weekly & monthly report outs and escalation of significant issues when required.
  • Responsible for maintaining /modifying and updating the Tecate facility layout.
  • Prioritize and manage all new product prototyping.
  • Participate and assist as a part of the Internal Audit team as required.
  • Acts as a consultant for areas related to his/her expertise.
  • Ability to develop an understanding and practice of Nordson values and competencies.

Experiencia y requisitos

MINIMUM QUALIFICATIONS:

To perform this position successfully, an individual must be able to perform each job duty satisfactorily.  The  requirements listed below are representative of the knowledge, skills, and/or abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.


Required Education:          

  • Bachelor’s degree in engineering or related technical field


Required Length & Type of Experience:

  • Minimum 7 years’ experience required in manufacturing industry, preferably in medical device manufacturing
  • Previous technical/engineering management experience.
  • Experience in advanced engineering & statistical problem-solving methods is desired, including Six Sigma training.  Six Sigma Green Belt or Black Belt certification is desired.


Knowledge, Skills & Abilities (KSA’s):

  • Knowledge of ISO 13485:2003, GMP, FDA, QSR. European quality systems requirements (QSR, MDD), and risk management (ISO 14971, DFMEA and PFMEA)
  • Understanding of common machine shop practices, fixture design and assembly techniques.
  • Well-developed written and verbal communication skills in English and Spanish. Ability to write and comprehend instructions, short correspondence, and memos in both English and Spanish.  Interaction with customer is expected in this position.
  • Must exhibit good project management, and interpersonal skills, and the ability to balance priorities and workload while working in a team environment

Beneficios

  • Beneficios de acuerdo a la LFT
  • Vales de despensa
  • Fondo de ahorro

Número de vacantes 1

Área Ingeniería

Contrato Permanente

Modalidad Presencial

Turno Diurno

Jornada Tiempo Completo

Horario
  • Lunes a Jueves de 7:00 a 18:00 horas y viernes hasta 13:00 horas
  • Tiempo completo
  • Turno Matutino

Estudios Carrera con título profesional

Inglés Hablado: Avanzado, Escrito: Avanzado

Disponibilidad p. viajar No