Quality Assurance Specialist

hace 3 semanas


Monterrey, Nuevo León, México Baxter A tiempo completo

About Baxter

Baxter is a leading global medical technology company that creates innovative products and therapies that transform healthcare.

Your Role

As a Quality Engineer at Baxter, you will play a critical role in ensuring the quality and compliance of our medical devices. You will be responsible for developing and coordinating the quality and regulatory strategy for the site, overseeing product development compliance, and participating in special projects and initiatives.

Key Responsibilities

  • Provide leadership and oversight for the development and coordination of the quality and regulatory strategy for the site.
  • Oversee product development compliance for medical devices area. Respond to regulatory issues concerning products and business processes.
  • Participate in special projects and initiatives, as requested.
  • Review and assure that any noncompliance associated with manufacturing processes, audit findings, complaints, design processes, etc. are addressed in a timely manner and that appropriate corrective and preventive actions are taken.
  • Assure quality metrics for the assigned area (RTY/FPY/NCMRS).
  • Drive continuous improvement in supplier performance through utilization of tools such as DMAIC, FMEA, SPC, 8D Root Cause Analysis, and Lean.
  • Respect of Ethics and Data Privacy requirements.
  • Responsible to coordinate inspection and testing in production lines.

Requirements

  • Bachelor's degree in Engineering Science.
  • A minimum of 2 years' experience in Quality Assurance or Regulatory Affairs, with medical device experience preferred.
  • Proven experience in driving continuous improvement in product performance through utilization of tools such as DMAIC, FMEA, SPC, 8D Root Cause Analysis, and Lean.
  • English intermediate.
  • Visa up to date.
  • Work with Assembly environment preferable.


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