Middle QA Engineer IRC271661

Description

The purpose of the project is a Clinic-Patient Web system which serves medical devices data upload, storage and data analysis via reports.

Requirements

We are looking for an organized, detail-orientated, and proactive Manual Quality Assurance (QA)
Engineer. You would design and execute tests of device firmware and manufacturing process software in
support of our Class II monitoring devices.
In this role, you will act as an advocate for the quality of our software, from the perspective of both our
patients and our internal customers, working primarily with firmware written in C and with C#/.NET
windows desktop applications.

Understanding of QA principles and processes.

•  Preference for experience with the software QA process in the medical device industry
  (ISO 13485, ISO 62304) or other regulated environment (e.g., FAA, SEC, DoD, Title 21
  CFR part 11), and related verification, validation, and documentation requirements.
• Understanding of requirements traceability and its role in compliance and test coverage
• Proactive communicator with ability to work independently as well as collaboratively in cross-
  functional teams.
• Clear, concise, and organized written communication skills to convey methods and observations.
• Familiarity with defect tracking tools (ideally JIRA)
• Experience in test management systems (preferably Jama Connect) including writing test cases,
  entering results, and facilitating review and sign-off processes.

• Experience with electronic test equipment (power supplies, DMMs, oscilloscopes, etc) and ability to troubleshoot electrical and firmware issues on circuits/hardware.

   

Job responsibilities

• Perform manual system-level, functional, and acceptance testing on embedded systems software
  (C) and supporting desktop software applications (C#/.NET).
• Perform software tool validation: write requirements, write and execute protocols for both custom
  and off-the-shelf software tools used during V&V.
• Perform exploratory and ad-hoc testing to identify edge cases and unexpected system behavior
  not captured by formal test protocols.
• Develop written verification test protocols, then subsequently document and report test results in
  a manner consistent with regulatory standards and internal procedures.
• Review requirements and design documentation to ensure technical accuracy as well as
  testability; act as a quality advocate throughout the development process.
• Support document release processes using our electronic document control systems
  (MasterControl), including submitting documents and routing for review and approval.