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

Lead all aspects of ensuring Quality System Regulation compliance for Quality and Manufacturing Processes. Provide technical support to Aibonito facility.

Your Team

At Baxter, our mission to save and sustain lives is embedded into everything we do, driving our dedication to quality over quantity. Our team values both collaboration and autonomy, growing in environments that promote partnership, whether in a plant or office setting. As a part of our ambitious and world-class team, you will build relationships grounded in trust, reliability, and ethical conduct. We encourage an open dialog, allowing team members to share new insights and opportunities for continuous improvement. This collaborative spirit ensures that we produce top-of-the-line products for our customers.

What we offer from day 1:

• Vacation and Paid Holidays
• Medical, Dental, Disability and Life Insurance coverage
• Vision and Voluntary Benefits
• Paid Parental Leave
• Retirement Savings Plan – 165E
• Employee Stock Purchase Program
• Educational Assistance Plan

What you'll be doing

• Ensure compliance and provide Quality mentorship for process/area responsibilities.
• Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules, guidelines, and Baxter quality practices.
• Lead and conduct root cause investigations for multi-group projects, encouraging continuous improvement and corrective/preventative action strategies.
• Support the Aibonito facility with technical knowledge, modification specifications, procedures, special tests, and/or projects.
• Maintain full knowledge of the Quality Operations.
• Participate in the process validation and protocols of equipment and/or subassemblies.
• Participate in the Software Validations and Protocols of equipment and/or database applications.
• Engage in Quality Programs and ensure compliance with GMP, FDA, ISO, and other Regulatory Agencies.
• Review documentation for compliance with GMP and GDP.
• Support the design, development, and improvement of product processes and technology modifications.
• Evaluate customer complaints and conduct Non-conformance Investigations, providing approvals as a quality representative.
• Develop and evaluate Quality Sampling Plans and techniques for further improvement.
• Coordinate the Continuous Process Verification (CPV) program and any special projects assigned.
• Observe all company and regulatory EHS requirements.
• Prepare monthly and quarterly Quality Data Reviews.
• Participate in internal and external audits.
• Analyze Defects per Million (DPM) per defect/product monthly, considering equivalent experience.
• Lead assigned programs (e.g., Sterilization, Parametric Release) from a quality standpoint to ensure compliance, reviewing and approving related documentation.
• Evaluate sterilization alarms and provide final product disposition based on procedures and specifications.
• Provide feedback and support to steam sterilization projects as a subject matter expert.
• Perform any necessary work to avoid delays in product release.
• Apply Computer Programs (e.g., Microsoft Office, Outlook, Trackwise, TcU).
• Coordinate and participate in meetings with multidisciplinary teams as required.
• Prepare reports for management review and quality data indicators.
• Work effectively within a team-oriented environment.
• Manage multiple tasks simultaneously with minimal supervision.
• Align with established project objectives and timelines.
• Communicate effectively at all plant levels.

Physical demands:

Light Work: Exerting up to 20 pounds of force occasionally and/or 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. This role may require significant walking or standing, pushing and/or pulling of arm or leg controls, and working at a production rate pace.

What you'll bring

• Bachelor’s Degree in Engineering.
• At least one-year experience with statistical applications knowledge.
• Proficiency in engineering and management practices, statistical methods, computer systems, and technical reporting.
• A self-starter with an in-depth understanding of Quality day-to-day activities.
• Effective communication skills across all levels of personnel.
• Ability to supervise efficiently and in a timely manner.
• Willingness to travel occasionally.
• Fully bilingual (English & Spanish).

Disclaimer statement

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this classification. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

Join our dedicated team at Baxter Healthcare Corporation and be part of our mission to improve healthcare outcomes for patients worldwide. Apply today and take the next step in your career!

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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
Pay Transparency Policy

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.