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Software Systems Quality Assurance

Company: W.L. Gore & Associates
Location: Phoenix
Posted on: February 12, 2024

Job Description:

About the Role:

We are looking for multiple Software Systems Quality Assurance Associates to join our Quality team focused on delivering software systems that will increase the speed of medical product innovation, result in meaningful business process efficiencies, and improve overall Associate experience in alignment with our Medical Product Division's (MPD) digital transformation initiatives. In this role, you will partner with a cross-functional team to support the development or revision of business processes and workflows as they are created and/or transitioned to new systems. You will ensure implemented solutions are developed in accordance with and meet applicable regulations and standards, MPD Quality System requirements, and project objectives with a focus on providing solutions that support a sustainable, scalable, and simplified quality system.

These positions will be located at one of our facilities in Phoenix, Arizona or Flagstaff, Arizona, with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.


  • Partner with cross functional system implementation teams to ensure integration and alignment with business objectives for targeted processes
  • Support planning and execution activities for the transition of quality processes, through partnership with MPD and Enterprise cross functional System Implementation teams
  • Provide Quality Assurance (QA) support to Associates who will author or revise procedures, quality plans, etc., to facilitate the development, transfer, and sustainment of workflows into new systems
  • Support the documentation of quality system specific user requirements and ensure these requirements are met
  • Partner with appropriate functions/Associates to mentor teams, influence data migration strategy, re-write and validate procedures, and document the execution of this work in the quality system
  • Partner with Training Associates to develop, deliver, and document training
  • Provide feedback on the usability and functionality of new processes and systems
  • Be agile, flexible, and open to make unique or unconventional changes and at the same time ensure QS compliance; be comfortable to handle risk and uncertainty based on a well vetted and appropriate assessment
  • Maintain compliance with training expectations as required for this position
  • Additional responsibilities as required within the scope of position

    Required Qualifications:
    • Minimum of 3 years in a Quality Assurance (QA), Engineering or Manufacturing operations role in the medical-device or pharmaceutical industry or
    • Demonstrated history of partnering and influencing teams cross-functionally
    • Excellent written and oral communication and presentation skills
    • Ability to identify and prioritize tasks to help drive projects to completion
    • Ability to self-direct and work independently

      Desired Qualifications:
      • Previous computer system validation or computer system software assurance experience through the software development lifecycle for enterprise software solutions (PLM, MES, ERP, or similar)
      • Previous New Product Development/Design Control Experience

        Hybrid Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's hybrid working policies, from the country in which they are employed.

        What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

        We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at

        We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.

        Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

        Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

        Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.

        Our Talent Acquisition Team welcomes your questions at

Keywords: W.L. Gore & Associates, Phoenix , Software Systems Quality Assurance, IT / Software / Systems , Phoenix, Arizona

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