Senior Quality Engineer

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.

Your role at Baxter:

Coordinates the scheduling and control of quality resources, and compliance requirements according to the specifications of raw materials, product, packaging and regulatory agencies, manage the ongoing regulatory compliance for your area, including quality systems.

Supports resources and quality functions related to sustainment projects under the direction of the supervisor and establishes and maintains systems through quality control standards and procedures for the designated area.

Supports quality resources and functions related to sustainment projects under the direction of the supervisor.

What you'll do be doing

• Ensure compliance with QSR regulations part 820, ISO-13485 and other applicable regulations and ensure compliance with QSR part 820, ISO-13485 and other applicable regulations.

• Ensure and report metrics to monitor quality performance.

• Ensure that the process of non-conforming material is execute according to established procedures complying with the determined metrics.

• Support with the creation, maintenance and when apply improvement of work instructions.

• Support with validation activities, IQs, TMVs, OQs, PQs, for designated areas

• Lead or participate in NCR, SNCR, CAPA activities in accordance with established procedures and ensuring compliance with quality objectives

• Assists department management and staff in the implementation of statistical control techniques quality in order to improve efficiency and operational effectiveness .

• Responsible for the analysis of data obtained from the field to investigate and solve problems identified through the reports of Post Market Surveillance report.

• You can participate in project transfers through the identification and correction of gaps identified in the manufacturing processes, establishing product acceptance criteria, ensuring quality controls and supporting compliance with projects datelines

• Participate in Value Stream projects (quality improvements, cost savings, increased productivity)

What you'll bring

• 3 to 5 years of quality experience

• Advance level of English

• Bachelor's degree in Industrial Engineering or related.

• Training / Knowledge on risk management ISO 14971 and ISO13485

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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