Tandym Group
Sr. QA Engineer
Tandym Group, Irvine, California, United States, 92713
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 reviewProvide and implement effective solutions that will drive continuous and measurable improvementsIntegrate ISO 14971, risk management and IEC 62366 usability engineering activities with processesMentor and provides direction to software development teams in design controls and lead risk management activitiesFoster and maintains organizational compliance to the quality systemProvide CAPA, complaints, audit and overall QMS support in regards to softwarePerform other related duties and projects, as neededQualifications:
8+ years of experience in Software Design assurance in the FDA QSR/ISO 13485 medical device industryBachelor's Degree in Computer Science, Software Engineering, Informatics, Biomedical, or related technical fieldExperience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk management) and IEC 62366 Usability EngineeringExperience with Agile software development methodologies like Scrum and KanbanExperience with other than embedded software development areas, such as web developmentPrevious experience with digital health, Health IT or mobile medical applicationsAdvance knowledge with development and test requirements with recognized standards (ISO 13485)Demonstrated knowledge and understanding of software development, including cloud computingDemonstrated ability to implement and improve Software QMS processesDemonstrate 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 skillsGreat interpersonal skillsExcellent communication skills (written and verbal)Strong attention to detailHighly organizedDesired Skills
Previous experience with Cloud-based softwareKnowledge of CAD/CAM and AI/ML
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 reviewProvide and implement effective solutions that will drive continuous and measurable improvementsIntegrate ISO 14971, risk management and IEC 62366 usability engineering activities with processesMentor and provides direction to software development teams in design controls and lead risk management activitiesFoster and maintains organizational compliance to the quality systemProvide CAPA, complaints, audit and overall QMS support in regards to softwarePerform other related duties and projects, as neededQualifications:
8+ years of experience in Software Design assurance in the FDA QSR/ISO 13485 medical device industryBachelor's Degree in Computer Science, Software Engineering, Informatics, Biomedical, or related technical fieldExperience with the application of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk management) and IEC 62366 Usability EngineeringExperience with Agile software development methodologies like Scrum and KanbanExperience with other than embedded software development areas, such as web developmentPrevious experience with digital health, Health IT or mobile medical applicationsAdvance knowledge with development and test requirements with recognized standards (ISO 13485)Demonstrated knowledge and understanding of software development, including cloud computingDemonstrated ability to implement and improve Software QMS processesDemonstrate 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 skillsGreat interpersonal skillsExcellent communication skills (written and verbal)Strong attention to detailHighly organizedDesired Skills
Previous experience with Cloud-based softwareKnowledge of CAD/CAM and AI/ML