SQAFYI - Software QA Resource - FYI

US-MA-Natick: Software Quality Control Engineer

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Date: 11-Sep-2018

Software Quality Control Engineer (SQC)


Work with QA to ensure Pillar software development process conforms to applicable regulatory requirements including IEC62304, ISO14971 and ISO 13485. Draft and maintain software design input requirements, specifications, and technical design documents. Provide timely and meaningful feedback to QA and Software development. Work with software product development team to evaluate software interfaces, operational requirements, and performances. Define necessary test methods and create test plans for new or updated software. Have knowledge about continuous integration and all basic test methods including regression, integration, and unit tests. Responsible for the design traceability matrix. Execute tests and generate test reports to describe program evaluation, testing, analysis, and corrective action. Recommend design improvements or corrections to software engineers throughout the development process. Develop test scripts when needed. Ensure new products have been fully verified prior to their release, and that these designs meet documented and implied user needs in compliance with applicable standards and regulations. Maintain effective communication with QA on project limitation, capability, performance requirement and hardware interface changes.



Bachelor’s Degree or equivalent in Computer Science or related technical field


2+ year of Experience and knowledge with ISO 13485, IEC 62304, ISO14971, 21CFR§11. 2+ year of software engineering and testing experience in a product development environment 2+ year of prior experience with software documentation and design input. Knowledge of Linux/Unix, command line, scripting and Python Knowledge, Skills, and Abilities. Excellent analytical skills. Strong interpersonal skills with ability to work both independently and as part of a team. Excellent written and verbal communication skills. Proficient with Microsoft Office (Word, Excel, PowerPoint) Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks.

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Thank you,
Team SQAFYI - Software QA Resource FYI

US-MA-Natick: Software Quality Control Engineer