QA Systems 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

This document outlines the employment prerequisites and job responsibilities for the Quality Assurance Systems Engineer position.

Your Team

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.

Our company 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 establish 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 we offer from day 1:

• Paid Time Off and Paid Holidays

• Medical, Dental, Disability and Life Insurance coverage

• Vision and Voluntary Benefits

• Paid Parental Leave

• Retirement Savings Plan

• Employee Stock Purchase Program

• Flexible Health Care Spending Accounts

• Educational Assistance Plan

What you'll be doing

Reporting to the QA Systems Manager, the primary responsibilities are:

• Support and execute complex validations, including IQ, OQ, PQ, and MSA protocols and reports for processes, equipment, test methods, and computerized systems within the facility throughout the validation stages with little or no guidance.

• Own and drive change control based on procedural requirements

• Assist, present, defend, and communicate with external auditors and other validations or projects in which you lead or participated.

• Assist or lead process improvement projects (scrap reduction, defect reduction, etc.) with little or no guidance.

• Work collaboratively with a cross-functional team (production, quality, laboratory, etc.)

• Apply solid technical understanding of engineering principles and procedures (e.g., CAD and its application or scheduling a series of technical tasks utilizing software-based tools and/or specialties such as electrical, mechanical, chemical, industrial, or biological).

• Assists in the preparation and participation of technical reviews and is responsible for organizing data and preparing appropriate documentation for assigned projects.

• Assist management or other engineers during process design, equipment installation, qualification, and/or process monitoring.

• Provide technical reports and/or data-driven analysis after training.

• Other duties as assigned

What you'll bring

• Bachelor's degree in Engineering

• 1-3 years of engineering experience preferred

• Interest in obtaining certifications (ASQ) Experience in the manufacturing and/or medical device industry preferred, including experience in the development and deployment of Quality Systems.

• Prefer experience and/ or training with process improvement methods (e.g. six sigma, lean)

• Experience with technical communication, cross-functional collaboration, problem-solving, root cause analysis, and applying engineering principles.

• Basic understanding of validation guidelines, cGMPs Regulations, and Good Manufacturing Practices, preferred.

• Expert multitasker with solid prioritization skills is essential

• Support plant initiatives with the development and implementation of new processes/technologies

• Highly motivated to learn and accomplish goals

• Ability to meet tight deadlines.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $72,000.00 - $99,000.00 USD annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors.

PHYSICAL DEMANDS

• Must be able to sit, stand, or walk throughout the workday.

• Ability to lift and carry up to 20 pounds and perform repetitive hand/finger motions.

• Good hand-eye coordination and dexterity required.

• Dynamic lifting capability: lift 15 pounds floor to shoulder, 2 pounds overhead; push/pull with up to 6 pounds of force.

WORK ENVIRONMENT

The work environment is a regulated manufacturing facility governed by FDA and internal quality standards. Employees are expected to comply with all applicable rules and procedures designed to maintain product integrity and safety.

Conditions and requirements include:

• Wearing a static protective smock and wrist strap while in designated areas.

• Working in close proximity to others in a temperature- and humidity-controlled environment.

• Compliance with cleanroom or ESD (electrostatic discharge) protocols as required.

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.

Know Your Rights: Workplace Discrimination is Illegal

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.