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Sr. QA Engineer

2 months ago

Irvine, United States Tandym Group Full time

A recognized medical services company in California is currently seeking a new Senior QA Engineer for a promising opportunity with their growing staff. In this role, the Senior QA Engineer will be responsible for leading the ongoing implementation of Software Quality Management System (QMS) through the integration of internal and external/medical device industry best practices.

Responsibilities:

The Senior QA Engineer will:

  • Oversee the administration of the QMS software.
  • Conduct investigations and provides corrective and preventive actions based on analysis and review
  • Provide and implement effective solutions that will drive continuous and measurable improvements
  • Integrate ISO 14971, risk management and IEC 62366 usability engineering activities with processes
  • Mentor and provides direction to software development teams in design controls and lead risk management activities
  • Foster and maintains organizational compliance to the quality system
  • Provide CAPA, complaints, audit and overall QMS support in regards to software
  • Perform other related duties and projects, as needed
Qualifications:
  • 8+ years of experience in Software Design assurance in the FDA QSR/ISO 13485 medical device industry
  • Bachelor's Degree in Computer Science, Software Engineering, Informatics, Biomedical, or related technical field
  • Experience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk management) and IEC 62366 Usability Engineering
  • Experience with Agile software development methodologies like Scrum and Kanban
  • Experience with other than embedded software development areas, such as web development
  • Previous experience with digital health, Health IT or mobile medical applications
  • Advance knowledge with development and test requirements with recognized standards (ISO 13485)
  • Demonstrated knowledge and understanding of software development, including cloud computing
  • Demonstrated ability to implement and improve Software QMS processes
  • Demonstrate knowledge of group software development methods (Agile Process and Scrum Method)
  • Advance knowledge on writing, executing and monitoring automated test suites using a variety of technologies (Selenium, WebDriver, JavaScript and Nodejs)
  • Solid problem solving and time management skills
  • Great interpersonal skills
  • Excellent communication skills (written and verbal)
  • Strong attention to detail
  • Highly organized
Desired Skills
  • Previous experience with Cloud-based software
  • Knowledge of CAD/CAM and AI/ML

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