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Baxter Healthcare Corporation Principal Quality Engineer in Jayuya, Puerto Rico

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

This is where your creativity addresses challenges

You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As aPrincipal Quality Engineer, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What you'll be doing

Provides support, supervises, coordinates, implements, and develops all activities related to calibrations, environmental tests, sterilization qualification studies and critical systems in compliance with all legal and regulatory standards. Supervise the Sterilization area leading and performing technical duties at steam sterilization stations to achieve production schedule. Coordinate resources at the steam sterilization operation to mass-produce intravenous IV bags solutions products. Assure that all operations are in compliance with all Company standards.

  • Supervises and provide technical support to all activities at the Critical Systems Area.
  • Maintain full compliance of critical systems area, calibrations and qualifications of steam sterilizers.
  • Approves and assure that all reports related to calibrations, steam sterilizers qualifications, critical systems and environmental test follow internal procedures, policies and external regulations.
  • Fill out reports and the necessary documentation to follow specifications and SOP's.
  • Prepare reports, such as monthly highlights, calibrations and steam sterilization cycles out of limit trends on a timely basis at a frequency required by the immediate supervisor.
  • Coordinates, schedules, assign and establishes goals at the Critical Systems Area.
  • Perform internal audits to assure compliance with Local and Federal agencies.
  • Perform nonconformance investigations and implement corrective/preventive actions as required.
  • Review specification changes and align with SAR systems requirements
  • Reviews Corporate policies changes, perform gap analysis and implementation and ensure that the Critical System area complies with requirements.
  • Initiates and implement changes to existing procedures or create new procedures related to calibrations, qualifications of steam sterilizers or critical systems.
  • Develop, modify, analyze and review protocols.
  • Assure continuity of department projects.
  • Develop and implement plans to reduce the Plant overhead costs for areas of responsibility.
  • Keep the working area clean and organized to align with the 6S and lean concepts.
Supervisory Responsibilities:
  • Directly supervises 5 - 8 employees in the Critical Systems Area. Responsible for the overall direction, coordination, and evaluation of this unit. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and advising work; appraising performance; rewarding and focusing employees; addressing complaints and resolving problems.
What you'll bring
  • Bachelor's degree (BS) in Engineering; three to five years related experience and/or training; equivalent combination of education and experience is a must. Knowledge in 21 CFR Part 211 and ISO 9001 current revision, highly desirable

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.



Reasonable AccommodationsBaxter 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 NoticeBaxter 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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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.

EEO is the Law
EEO is the law - Poster Supplement
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