Eng I, Quality

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. 

SUMMARY:
Responsible for insuring compliance with the Quality System Regulation regarding Quality and Manufacturing Processes and methods. To perform effectively the incumbent must be knowledgeable of processes, product specifications and quality functions. Participate/Create protocols, first of codes, non-compliances and exceptions evaluation, changes of specs. SOP’s, special tests and /or projects.

TAREAS Y RESPONSABILIDADES (DUTIES AND RESPONSIBILITIES):
1. Participate and maintain full knowledge of the Operations / Management Review.
2. Meets with manufacturing and Process/Product Engineering to assist in the implementation/evaluation of new or improved process and equipment.
3. Participates and/or creates process validation and protocols of equipment and or new subassemblies.
4. Keep in compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies.
5. Support the design, development enhancement of new product processes and technologies.
6. Evaluation of customer complaints and implementation of Corrective and preventive Actions.
7. Owner of non-conformance investigation and audits item.
8. Any special project as assigned.
9. Evaluate product or process performance and improve them accordingly. Define control limits as applicable.
10. Observes all company and regulatory EHS requirements.
11. Develop and implement procedures for process control and testing. Validate test methods related with product manufacturing process.
12. Evaluate failure modes (PFMEA) related with process, product and machines.
13. Identify and develop VIP projects.
14. Identify hazards and evaluate risks and environmental aspects of areas and processes under responsibility and implement appropriate control.
15. Identify and evaluate all risks and environmental aspects of the area of responsibility. Able to recognize new risks.
 

EDUCATION AND/OR EXPERIENCE:

Bachelor’s degree in science (B.S.) –, Pharmacy, Industrial Engineering or related field. Other bachelor’s degrees may be considered if it is commensurate with significant quality assurance experience in a Medical Devices or regulated industry.

One to Two years of experience in Quality

LANGUAGE:
Fully bilingual (English and Spanish).

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.

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.