Haina, San Cristóbal
1 day ago
Eng II, Quality Engineering

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

About Us: Baxter’s Mission:

 

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 90 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:

As a Engineer II, Quality Engineering you i’ll be responsible for insuring compliance with the Quality System Regulation regarding quality and manufacturing processes and methods.  You i’ll provide support and service to their respective areas, ensuring they are in compliance with internal and external regulations.  Provide the Haina facility with technical/statistical support to assure process control. Participate/Create protocols, first of codes, non-compliances and exceptions evaluation, changes of specs. SOP’s, special tests and /or projects. As well, you I’ll be part of risk assessments, and test method validation initiatives.

 

Your team:

We develop quality products with the patient in mind, so our efforts are also patient-centric. That means you can be proud of our work and the value we provide to people every day. As a large, multinational organization, you have the opportunity to expand your knowledge through collaboration with a variety of individuals, exposure to different facets of our portfolio, and a supportive leadership team that encourages ongoing development.

 

The quality team is characterized by supporting the business fast, simple, agile but complying with quality requirements.

 

What you’ll be doing:

Participate and maintain full knowledge of the Operations / Management Review.Meets with manufacturing and Process/Product Engineering to assist in the implementation/evaluation of new or improved process and equipment.Participates and/or creates process validation and protocols of equipment and or new subassemblies.Participates in the Software Validations and Protocols of equipment and/or database applications.Keep in compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies.Support the design, development enhancement of new product processes and technologies.Evaluation of customer complaints and implementation of corrective and preventive actions.Owner of non-conformance investigation and audits items as applicable.Evaluate product or process performance and improve them accordingly. Define control limits as applicable.Develop and implement procedures for process control and testing. Validate test methods related with product manufacturing process.Evaluate failure modes (PFMEA) related with process, product and machines.Identify and develop VIP projects.Participates in quality initiatives such as Risk Management, TMV, among others.

 

What you’ll bring:

Bachelor's degree in science (B.S.) –, Pharmacy, industrial engineering, or related field.3 -5 years of experience in quality or related areas.Experience in validation processes, manufacturing process of medical devices and implementation of projects.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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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