The Software Quality Assurance Engineer Lead is a technical position responsible for testing and verification of software solutions developed at Full Spectrum Software and by our clients. The SQA Lead is responsible for mapping design requirements into test protocols and execution of verification and validation test protocols against product requirements within schedule constraints, meeting quality standards and goals.
Much of our work is in the medical device field. The ideal candidate will be an experienced SQA engineer for FDA-regulated medical device software and/or software solutions involving hardware interfaces. Good understanding of testing methodologies for desktop, embedded, and mobile systems is a big plus.
This is a full-time position at our facility in Southborough, MA, but will be remote for a while. Contractors from out-of-state can work remotely through the end of the contract.
Responsibilities
Review requirements specification documents and develop Test Plans.
Estimate, plan, develop, execute, and maintain test cases and test protocols for products under development.
Perform Software, Hardware, Application, GUI and Back-End testing.
Create automated tests as appropriate using established framework.
Ensure that FDA-regulated medical products are tested in adherence to the applicable standards and regulations (ISO 13485, IEC 62304) and best practices.
Work with project management to meet the testing milestones and deliver high quality solutions on time.
Required Qualifications
9+ years of software development testing experience.
5+ years of medical device or life science software testing experience
3+ years of experience with manual testing of software for hardware control or embedded systems.
Experience testing products in various operating environments, such as:
- Microsoft Windows
- Embedded Linux / Kiosk
- Mobile iOS and/or Android
- Web
Experience with verification of regulated medical device software.
Experience in estimating, prioritizing, planning and coordinating testing activities.
Experience developing and maintaining comprehensive test documentation and requirements-to-tests traceability.
Essential Skills
Strong hands-on test case and test protocol writing skills.
Good understanding of ISO 13485 and ISO 14971 standards
Thorough understanding of smoke testing, black-box, and non-black box testing, as well as regression testing.
Understanding of all phases of the Software Development Life Cycle
Excellent troubleshooting skills to help isolate the cause of a defect.
Strong oral and written communication skills.
Flexibility to balance multiple assignments in a fast-paced environment.
Ability to interact directly with clients.
Must possess a strong sense of ownership, responsibility, and initiative.
Bachelor’s degree in computer science, engineering, science, or related discipline.
Pluses/Nice to have
Experience working with real-time software products and networking products.
Experience with web and client/server technologies, relational databases, network and infrastructure
Experience with creating autonomous testing for both software and hardware-embedded systems.
Experience using TFS, Jira or equivalent.
Experience using SQL/T-SQL.
Experience with Agile Application Development and Scrum methodologies.
Competitive salary and benefits including 401k, paid vacation time and health insurance.
Job Types: Full-time, Contract
Pay: $120,000.00 - $130,000.00 per year
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