Specialist Quality Engineer - Monterrey, México - BAXTER

BAXTER

Empresa verificada

Monterrey, México

hace 1 día

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world.

You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

DUTIES AND RESPONSIBILITIES:

Provides leadership and oversight for the development and coordination of the quality and regulatory strategy for the site.
Oversees product development compliance.
Responds to regulatory issues concerning products and business processes.
Works with inside and outside legal counsel in providing regulatory services to the facility.
Participates in special projects and initiatives, as requested.
Manages customer complaint process, including review, trending, and internal / external customer feedback.
Reviews and define business critical operating measures, and assures 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.
Determine quality metrics for the assigned area.
Assures that all personnel from the assigned area are trained and compliant with internal and external regulatory requirements.
Assures appropriate training files are maintained.
Develops and manages the department budget and resources.
Drive continuous improvement in supplier performance through utilization tools such as DOE, Six Sigma, DMAIC, FMEA, SPC, 8D Root Cause Analysis, and Lean.
Respect of Ethics and Data Privacy requirements
Responsible to coordinate inspection and testing in Assembly product line
Managing CAPA related with assigned area.

EDUCATION

A minimum of 38 years' experience in Quality Assurance or Regulatory Affairs, with medical device experience preferred.
College degree required, with preference to engineering or scientific disciplines.

EXPERIENCE AND QUALIFICATIONS:

Work with Assembly environment preferable.
A successful track record related to assuring compliance to all applicable regulations and established Quality System standards (i.e., QSR, MDD, CMDCAS, ISO 13485 & ISO 9001).
Able to view processes from a systems perspective and interpret details that impact the overall system.
Thorough understanding of process and continuous improvement principles such as Six Sigma, Lean, and Kaizen.

Reasonable Accommodations

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information.

To learn how you can protect yourself, review our Recruitment Fraud Notice.

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