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Sr. Software Quality Engineer

Company: BAXTER
Location: Opelika
Posted on: May 13, 2022

Job Description:

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 (cGMP)
  • Creates/updates Standard Operating Procedures, Work Instructions, Forms, etc. to maintain the validated state of systems.
  • Responsible for understanding internal and external requirements for systems under the scope of software validation
  • 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 completionProtocol/Test Execution
    • 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 reporting.
    • 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 systems.
      • 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 industry.
        • Solid understanding of project development/implementation processes.
        • 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. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -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 . 064244

Keywords: BAXTER, Columbus , Sr. Software Quality Engineer, IT / Software / Systems , Opelika, Georgia

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