Senior Quality Assurance Engineer

hace 5 días

Tijuana, Baja California, México Baxter Healthcare A tiempo completo

Job Summary

We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at Baxter Healthcare. As a key member of our quality team, you will be responsible for ensuring compliance with regulatory requirements and maintaining the highest standards of quality in our products and processes.

Key Responsibilities

  • Coordinate the scheduling and control of quality resources and compliance requirements to ensure adherence to regulatory specifications.
  • Manage ongoing regulatory compliance for your area, including quality systems, to ensure that all processes and procedures are in place and up-to-date.
  • Support resources and quality functions related to sustainment projects under the direction of the supervisor, establishing and maintaining systems through quality control standards and procedures.
  • Ensure compliance with QSR regulations part 820, ISO-13485, and other applicable regulations.
  • Develop and implement metrics to monitor quality performance and ensure that non-conforming material is executed according to established procedures.
  • Support the creation, maintenance, and improvement of work instructions and participate in validation activities, IQs, TMVs, OQs, and PQs for designated areas.
  • Lead or participate in NCR, SNCR, CAPA activities in accordance with established procedures and ensure compliance with quality objectives.
  • Assist department management and staff in the implementation of statistical control techniques to improve efficiency and operational effectiveness.
  • Responsible for the analysis of data obtained from the field to investigate and solve problems identified through Post Market Surveillance reports.
  • Participate in project transfers through the identification and correction of gaps identified in manufacturing processes, establishing product acceptance criteria, ensuring quality controls, and supporting compliance with project deadlines.
  • Participate in Value Stream projects (quality improvements, cost savings, increased productivity).

Requirements

  • 3 to 5 years of quality experience.
  • Advanced level of English.
  • Bachelor's degree in Industrial Engineering or related field.
  • Training/Knowledge on risk management ISO 14971 and ISO 13485.

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