FUJIFILM Healthcare Americas Corporation is looking to conduct manual and tool assisted testing of new and existing features in medical device software systems to ensure quality and compliance.
Requirements
- Basic coding/scripting skills.
- Testing experience in agile environments.
- Knowledge of web software, network and IT, medical devices, regulated environments.
- Working knowledge of DICOM, HL7, SQL, Oracle, IIS, scripting, JavaScript, TFS, MTM, PACS.
Responsibilities
- Create, modify, and execute exploratory test scenarios, with the goal of maximizing early defect discovery and eliminating issues discovered later.
- Develop test tool or use off the shelf tools to increase productivity.
- Support creation of automated regression tests or instructions for automation, as per the team’s definition of done.
- Develop/enhance a model of the system components that the team works on.
- Create or modify and execute test cases.
- Create or modify test data.
- Perform maintenance and upgrades to existing test environments.
Other
- Understand the scope/requirements of the project from requirements, user stories and interactions with the team.
- Report status and escalate issues effectively.
- Verify the accuracy of the product documentation.
- Coach and mentor less experienced team members in testing best practices.
- Add value in a team environment consisting of cross-functional members.
- Ability to take direction from Lead engineers and communicate issues and results in a timely manner.
- 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.
- BS degree or higher in a scientific, engineering, or clinical field.
- Good verbal and written communication skills.
- Determination to obtain results.
- Passion for using technology to innovate, in order to deliver the best clinician and patient experience.
- Enjoys working in a team and vice-versa.
- Ability to handle fluctuating workloads.
- Able to see the big picture as well perform detailed analyses.
- Self-directed and goal oriented.
- Awareness of and advocate for industry best practices.
- Able to guide QA team members.
- Occasional (up to 10%) travel may be required based on business need.