FUJIFILM AmericaRemote
Engineer II, Software Quality
United States of America
Full-time
2 weeks ago
H1B Sponsor Likely
Key skills
Software QADICOM standardAGILE Software developmentJIRAMicrosoft OfficeQuality system regulationsProblem solvingProject managementCommunication skillsJiraConfluenceAgileProject ManagementCommunicationProblem Solving
About this role
FUJIFILM Healthcare Americas Corporation is on a mission to innovate for a healthier world, focusing on cutting-edge healthcare solutions. The Engineer II, Software Quality role is centered on software functional testing and quality assurance, ensuring compliance with relevant procedures and documentation for software development.
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