Engineer II, Software Quality - Remote, United States

Position Overview · This position is intended to focus on software functional testing and quality assurance, and the fulfillment of relevant procedure and documentation per Fujifilm Medical Informatics Design Control process for software development. · Company Overview · At FUJIF ...

Job description

Position Overview

This position is intended to focus on software functional testing and quality assurance, and the fulfillment of relevant procedure and documentation per Fujifilm Medical Informatics Design Control process for software development.

Company Overview

At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier world, and we need passionate, driven people like you to help us get there. Our cutting-edge healthcare solutions span diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, as well as in-vitro diagnostics.

But we don't stop at healthcare; our Non-Destructive Testing (NDT) team harnesses advanced radiography solutions to keep transportation infrastructure, aerospace, and oil and gas assets safe and running smoothly.

Ready to innovate, collaborate, and make a difference? Join us and bring your big ideas to life while working in a dynamic, flexible environment that fuels your creativity and drive. 

Our headquarters is in Lexington, Massachusetts, an inspiring healthcare research hub in a historic town. 

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:

Job Description

Duties and 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.

Qualifications

Educational requirements:

• Bachelor's Degree (B.S./B.A.) or equivalent work experience in a scientific or technical discipline.

Experience:

• 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

Special skills or other job requirements:

• Detailed oriented.
• Problem solving
• Ability to multi-task.
• Highly organized.
• Project management skills.
• Excellent verbal, written, and communication skills.

Physical requirements

The position requires the ability to perform the following physical demands and/or have the listed capabilities:

• Usual office working conditions.
• Frequently required to sit, talk, or hear.
• Good manual dexterity.
• Ability to sit for extended periods.
• Occasionally lift and/or move up to 10 pounds.

Travel

• Occasional (up to 10%) travel may be required based on business needs.

*#LI-Remote

In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.
Applicants to positions where vendor credentialing or other similar requirements exist to enter facilities will be required to comply with the credentialing requirements of the facilities, including complying with vaccine requirements.
For all positions, the Company encourages vaccination against COVID-19 and requires that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors as required, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department or