Software Quality Assurance Engineer

at  Enlitic

ABOUT US

Enlitic is shaping the next generation of diagnostic healthcare tools to help patients around the globe. Using AI and deep learning, we help Radiologists identify disease and medical issues more accurately and earlier. We believe we are addressing one of the largest social impact opportunities in healthcare with our technology deploying around the globe. Enlitic is attacking the hard, high-value challenges facing healthcare by developing solutions others are afraid to touch. We are dedicated to the development of impactful healthcare solutions.

JOB DESCRIPTION

This is a remote position.

EDUCATION

• BS or MS Engineering degree

EXPERIENCE

• 2+ years of experience as an SQA Engineer performing structured software testing, including setting up automated tests and systems
• Experience working with software testing tools
• Experience in automated testing using a scripting language
• Experience working with complex instrumentation and hardware
• Experience creating test plans, regression tests, investigating test failures, logging bugs in a bug tracking system (JIRA), etc.
• Strong technical writing skills and proficiency using Microsoft Office applications
• Good organizational and communication skills, ability to work with minimum supervision
• Strong problem solver, critical thinker and active listener, good time management skills
• Familiarity with new product introductions (NPI), and product development life cycle activities
• Experience with ISO 13485, 62304 and FDA 510K and other global regulatory requirements
• Self-starter and quick learner
• Experience with API and Web Service testing is desired
• Knowledge of basic SQL and JavaScript is a plus

ISO/QMS REQUIREMENTS

• Understand and practice all requirements of EN ISO 13485:2016, ISO 13485:2016 MDSAP including 21 CFR 820, QMS Manual, Process Flows and Work Instructions. Experience with EN ISO 62304:2006 a plus.
• Comply with applicable regulatory requirements (including but not limited to MDSAP participating countries and CE Marking).
• Support Internal and External audits.

• Work with Cross-functional teams to drive alignment, procedure, and quality controls
• Work with our QMS and Regulatory team to ensure compliance with our QMS and regulatory policies
• Design and develop strong SOPs, policies, and a culture for our SQA Engineer team
• Create tests to identify software problems
• Analyze bugs and errors found during tests
• Document results of tests for the software development team
• Recommend improvements in software to enhance user experience
• Motivate the development process for efficiency and performance
• Works together with the software developer to enhance and improve programs
• Research and compare similar competitor products
• Maintain updated knowledge of industry trends and advancements
• Continue to develop and optimize test procedures for improving efficiency on test plan execution; design and create test cases for improving test coverage
• Perform device function testing based on given test plan and test cases
• Assist and troubleshoot issues during testing to avoid test blocking and schedule delays
• Develop, maintain, and expand test suites, test protocols and test cases
• Drive automation testing and economies of scale for productivity, effectiveness, and agility
• From time to time, you may be required to provide on-call engineering support for critical customer needs aligned with company policies and processes