Software Quality Assurance Engineer III

3 days ago

Bedford, Bedford, United Kingdom Werfen Full time

Job Summary:

Werfen, a leading developer, manufacturer, and distributor of specialized diagnostic instruments, seeks a highly skilled Software Quality Assurance Engineer III to join its R&D Software Engineering group. As a technical leader in the software quality assurance team, you will be responsible for developing, applying, and implementing software verification and validation methods to achieve product and systems quality goals.

Key Responsibilities:

  • Develop and execute software verification and validation activities, and report test results and defects to software development personnel.
  • Author documentation and participate in activities in support of design control.
  • Review and approve verification protocols, reports, and related commercial orders.
  • Identify product defects and recognize outliers in results, explaining and documenting product defects and their impact.
  • Effectively communicate complex technical information to a cross-functional team in the form of documentation, presentations, and/or technical summaries.
  • Review and approve Research & Development documents related to embedded software on new instruments.
  • Participate in software risk analysis activities.
  • Provide technical support for and/or lead investigations in support of development or on-market activities.
  • Provide input to and/or independently generate schedules for tasks related to assigned projects.
  • Provide technical guidance to other team members.
  • Recommend improvement initiatives to aid department practices.

Requirements:

  • Bachelor's degree in Information Technology, Computer Science, or a closely related technical field of study.
  • 5 years of experience in an occupation testing software within the in vitro medical device or clinical sector.
  • Background in performing software test automation using Java or Python, performing functional and non-functional tests, tracking issues and managing defects, and performing software validation and verification for testing in vitro medical devices.
  • Demonstrated expertise in manual test case authoring and reviewing, knowledge of SCRUM Agile methodologies and their application in a highly regulated sector, configuration management tools, cybersecurity vulnerability scanning, and external regulations for submissions for Software Contained in Medical Devices.
  • Strong verbal and written communication skills.

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