Engineer II, Software Quality

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.

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.

Together, we build a place where we are happy, successful, and encourage 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.

What you'll be doing:

As Eng II, Software Quality at Baxter Healthcare, you'll ensure flawless software meets high standards.

• Conduct periodical audits to ensure compliance with Baxter policy on software validations and audits.
• Validate hardware and software inventory control and ensure the use of original working copies of software applications.
• Support the Process Transfer and related activities for the facility, including software validation, labeling, and equipment validation.
• Participate and lead initiatives such as the POMs as required.
• Collaborate with manufacturing, product, and process teams to implement new or improved processes and equipment.
• Engage in Software Validations and Protocols of equipment and database applications.
• Facilitate long-term Quality Programs.
• Ensure compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies.
• Support the design and improvement of new product processes and technologies.
• Evaluate customer complaints and implement Corrective and Preventive Actions.
• Develop and evaluate Quality Sampling Plans and techniques for continuous improvement.

What you'll bring!

To be successful in this role, you will need a combination of technical expertise and interpersonal skills. You will be part of a world-class team that strives for perfection and continuous improvement.

• Bachelor’s Degree in Engineering, preferably Software or Industrial, with 2-3 years of experience, preferably in Medical Device or Pharmaceutical industries.
• Proficiency in Microsoft Office Software, Infrastructure Technology concepts, and Database concepts.
• Strong interpersonal skills.
• Knowledge of FDA, ISO, GAMP practices, OSHA Regulations, and Software Development Life Cycle.
• Fully bilingual (English and Spanish).

At Baxter Healthcare Corporation, we value diversity and are committed to being an equal opportunity employer. We do not discriminate based on race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. If you need accommodations during the application or interview process, or to perform essential job functions, please contact us.

Advanced Molding and Extrusion techniques (Learning / Doing (1)), Automation, reliability & smart manufacturing (Learning / Doing (1)), Critical Systems (Learning / Doing (1)), Data Analysis & Analytics (Applying / Overseeing (2)), Digitalization & Systems Engineering (Learning / Doing (1)), First Principles Thinking (Applying / Overseeing (2)), Lean & six sigma process knowledge (Applying / Overseeing (2)), Machine Learning & Artificial Intelligence (Not Applicable (0)), Manufacturing & Process Knowledge (Applying / Overseeing (2)), Modeling & Simulation (Leading / Driving (4)), Operational Quality Assurance (Learning / Doing (1)), Process Automation (Applying / Overseeing (2)), Product / Project Management (Applying / Overseeing (2)), Smart Operations / Industry 4.0 (Learning / Doing (1)), Software Integration (API, Data Pipelines) (Not Applicable (0))

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

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