Software Quality Engineer

Information Technology Irvine, California


Essential Responsibilities:

  • Reviews software requirements/specifications and provide quality feedback.
  • Collaborate with various departments to create, document and execute comprehensive tests plans and test cases.
  • Define and validate acceptance criteria.
  • Understand risk-based testing and establish quality goals.
  • Monitor all stages of business system software (implementation, continuous improvements, etc.).
  • Business system software requirements management owner.
  • Business system software change management owner.
  • Able to perform software configuration based on end user needs.
  • Support audit logistics during inspections.
  • Develop or source out automated testing solutions.
  • Assist in running reports in various applications for correct access and permissions.
  • Back up support for granting access to various business system software.
  • Assist with procedure development.
  • Support for ongoing review of separation of duties for key users/functions.
  • Assist with creating training and other necessary documentation.
  • Provide support for international compliance, where applicable.
  • Work alongside key departments that own key quality systems.
  • Work alongside project managers and departmental leads to evaluate new solutions, such as upgrades and add-on tools.

  • Bachelor’s degree in Information Systems, Quality Assurance, Software QA, or related field.
  • 3+ years in related role in medical device manufacturing
  • Experience interpreting large data sets and/or creating data analysis tools.
  • Experience in evaluating, using and/or supporting quality solutions, such as QMS, PLM, requirements management, training or related systems.
  • Experience with software validation planning and documentation.
  • Broad business and/or technical work experience.
  • Ability to translate technical jargon into executive friendly terms.
  • Demonstrate ability to work in a dynamic, collaborative environment
  • Strong written and oral communication skills, including an ability to articulate ideas clearly and appropriately influence others
  • Excellent organizational, interpersonal and teamwork skills
  • Well versed in project management skills.
  • Ability to thrive in a demanding, change-oriented, fast paced environment requiring a high degree of deadline-driven productivity.
  • Strong task management skills.
  • Ability to meet deadlines and handle and prioritize multiple requests.
  • Exceptional written communication skills and ability to communicate effectively at all levels of the organization.
  • Creative and analytical thinker with strong problem-solving skills.
  • Ability to work independently and manage multiple tasks while meeting deadlines.