What are the responsibilities and job description for the Sr. QA Engineer position at Tandym Group?
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)
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