Engineer II, Software Quality
United States of America
Full Time
2 weeks ago
H1B Sponsor Likely
Key skills
Software QADICOM standardAGILE Software developmentJIRAConfluenceMicrosoft OfficeMulti-taskingProblem solvingProject managementCommunication skillsDetail orientedJiraAgileProject ManagementCommunicationProblem Solving
About this role
FUJIFILM Healthcare Americas Corporation is focused on innovating for a healthier world through cutting-edge healthcare solutions. The Engineer II, Software Quality role is responsible for software functional testing and quality assurance, ensuring compliance with relevant procedures and documentation in the software development process.
Responsibilities:
- Have advanced knowledge about the Synapse Select product line, including deployment methods and deployment architecture for both on-premise and cloud configurations
- Create, maintain, and execute manual Software test cases for Verification and Validation protocols for the Synapse Select product line
- Occasional exploratory functional testing and ticketing of any issues found
- Reproduce and document any product defects and/or reported bugs in the JIRA development ticketing system
- Execute individual development ticket and regression testing with clear documentation of test results
- Correspond with Software and Template Engineering, give feedback to any questions they may have, and facilitate the provision of more information if needed
- Work with contractor QA team(s) on the grooming of development tickets and answer any questions they may have
- Participate in calls with the automated testing team for reviewing implementation of new test cases and give feedback for improvement of the protocol
- Create, Design Forms as required by the Medical Informatics Design Control Process for Synapse Select products as needed
- Occasionally help to address Corrective and Preventive actions (CAPA) assigned to Synapse Select as needed and complete in a timely manner
- Help to develop, document, and occasionally conduct internal technical trainings regarding new development for the Synapse Select product line
- Assist the Medical Informatics documentation team in the creation and maintenance of service manuals and product documentation for Synapse Select
- Assist Operations and Support with technical questions related to the Synapse Select product line. This may include attending customer meetings and additional items as necessary
- Additional responsibilities as defined by management
- Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and standards
Requirements:
- Bachelor's Degree (B.S./B.A.) or equivalent work experience in a scientific or technical discipline
- Minimum two (2) years of experience in Software Development, Software QA or other related fields
- Knowledge of software medical devices, procedures, and terminology, including the DICOM standard and HL7
- Knowledge of AGILE Software development and software design controls
- Knowledge of complaint handling and corrective and preventive action processes
- Knowledge of quality system regulations
- Experience with Microsoft® Word, Excel, Visio, and Access or equivalent software
- Experience with JIRA and Confluence
- Strong interpersonal, verbal, and written communication skills
- Detailed oriented
- Problem solving
- Ability to multi-task
- Highly organized
- Project management skills
- Excellent verbal, written, and communication skills