Quality & Process Engineer
BVI BEAVER VISITEC (INDUSTRIA MEDICA)
Ciudad Juarez, México
hace 21 días
source : Empleos Maquila

Descripción y Requisitos

Key Responsibilities :

  • Promote and implement activities to drive process standardization, efficiency, and cost reduction. Drive continuous improvements projects to deliver improved process capabilities, delivery, quality and cost.
  • Support manufacturing with operational problems with hands-on troubleshooting and process root cause analysis and corrective actions.
  • Establish best-in-class work practices to ensure quality and regulatory compliance.

  • Develop manufacturing process strategies through critical to quality (CTQ) attributes and translation of these requirements into new and improved manufacturing processes.
  • Identify and implement projects to maintain and enhance manufacturing operations.
  • Actively support, improve, and ensure compliance to the site quality management systems through documentation preparation, process auditing, and completion of corrective actions.
  • Effective BOM management
  • Design of medical kits
  • Optimize production schedules in accordance to customer demand and available capacity
  • Must have a thorough knowledge of proven techniques for solving problems such as : lean, DOE, statistical analysis, 8D, TQM methods, Six Sigma methodology
  • Education and Experience :

  • Bachelor of Science in an Engineering discipline.
  • Bilingual (Spanish - English).
  • Work experience in medical device manufacturing.
  • 3 to 5 years’ experience as a Process & Quality Engineer.
  • Previous Manufacturing validation experience (IQ / OQ / PQ) required.
  • Manufacturing Transfers.
  • Experience in Sealing and Packaging in medical products.
  • Strong leadership skills. Excellent organizational, interpersonal, and communication skills.
  • Demonstrated project management experience including design, execution resource management and start-up with a proven track record of achieving results.
  • Experience in technical problem solving and root cause analysis to drive improvements in manufacturing process capability, machine reliability and equipment output.
  • Ability to transfer and integrate new technology into a manufacturing environment including process startup and technical knowledge transfer.
  • Lean Manufacturing or Six Sigma certification.
  • Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR) & ISO 13485
  • Demonstrated skills in statistical analysis.
  • Experience participating in internal and external audits (e.g., FDA, Suppliers)
  • Experience with CAPA, complaint investigation, field action processes and risk management.
  • CQE, CQA preferred
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