Sr. Software Quality Engineer
Posted on: May 13, 2022
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
BaxterThis is where we make life-saving productsThe validations we
do and the products we help manufacture improve outcomes for
patients around the world. As a Sr. Software Quality Engineer at
Baxter, your work contributes directly to making a significant
impact on others. It's challenging work-and you're not on your own.
Our teams collaborate cross-functionally and lead by influence.
Whether guiding a team through a project or managing production
events, our quality team is responsible for supporting others to
achieve results, together!Our colleagues within our Quality
organization desire to work with products that make an important
difference in others' lives. We are motivated by the power of
collaboration and are natural leaders who are skilled at
influencing others.Your TeamWhile everyone at Baxter has a shared
passion for our mission, the Quality team plays a meaningful role
in our ability to save and sustain lives. Software Quality
Engineers, controls engineers, and IT specialists at the site work
together to develop and document validation packages,
documentation, test scripts, and change controls for needed changes
that ensure high quality, safe products for patient care.We courage
teamwork and collaboration and prioritize forming relationships
with each other. It's easy to do because we all share common traits
of reliability, ethics, and caring. We lean on our colleagues for
their expertise and hold each other accountable.We provide
opportunities to continue to learn through training, conferences,
certifications, and support for advanced degrees. Growth from role
to role or level to level is encouraged and is supported by
management to ensure employees are consistently engaged with their
work.What you'll be doingYou will be accountable for leading and
performing activities in support of the validation and compliance
of computerized systems and software to ensure systems meet the
intended use. You will apply a solid understanding of
theories/practices used by industry toward the validation of new or
enhanced computerized systems to plan, implement, and direct
important computer system validations. You will work with
Manufacturing, Engineering, and IT teams to validate Systems to
ensure compliance to applicable regulations (21 CFR Part 11, GxP
Regulations) and the Baxter Quality Management System.
- Prepares documentation in Baxter's document management system
per policy and procedure to support the validation of Systems
supporting manufacturing operations.
- Responsible for creating, managing, reviewing, and/or
maintaining the documents required for the development and
validation of new or changed computerized systems.
- Creates/Reviews validation documents in the project following
Software Development Life Cycle (SDLC).
- Writes, reviews, or assists with all computer system validation
documentation, including User Requirements Specifications, Design
Specifications, Qualification Protocols, Risk Analysis, Test Cases,
Test Defects, and Testing Summary Reports
- Understands and apply quality standards, Standard Operating
Procedures (SOPs), and Current Good Manufacturing Practices
- Creates/updates Standard Operating Procedures, Work
Instructions, Forms, etc. to maintain the validated state of
- Responsible for understanding internal and external
requirements for systems under the scope of software
- Identify and bring up, as necessary, project risks and issues
to the Project Manager and/or Site Leadership.
- Capable of managing projects from inception to
- Outlines testing based on the Risk Management strategy.
- Manages and implements validation testing plans and test cases
-executes the overall protocol process, including test case
creation/approval/execution/reviews, test case tracing to the
system requirements, test incident management, and status
- Maintains trace of the system requirements to the test cases
per Baxter QMS.System Support and Maintenance
- Drives System Inventory Management, Change Control, Problem
Investigation, and Periodic Review activities.
- Builds and reviews System Management Procedures and Manuals to
ensure Systems are maintained in validated state.
- Provides internal/external audit support for computerized
- Performs updates to documentation to maintain validation
documentation packages for computerized systems.What you'll bring
- Minimum BA / BS or relevant work experience in information
systems, engineering, science, or business.
- Thorough knowledge of GxP regulations (e.g. 21 CFR Part 11,
etc.), Standards, and Industry Best Practices.
- Experience in Software Development Life Cycle (SDLC) or
Software Validation within the Medical Device or Pharmaceutical
- Solid understanding of project development/implementation
- Proficient in the use of Microsoft Office Applications
Experience in HP ALM a plus to manage requirements and
testing.#LI-AD#IN-USOPSThe 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.Equal Employment
OpportunityBaxter 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. - - - - - - - - - - - - - - - - - - - - - - - - - -
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- - - - - - - - - - - - - - - - - - - - -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 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 .
Keywords: BAXTER, Columbus , Sr. Software Quality Engineer, IT / Software / Systems , Opelika, Georgia
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