Staff SW Design Quality Assurance Engineer needed in Acton, MA (remote/telecommuting position) by Insulet Corporation. Duties include but not limited to Quality Lead for Design Assurance of IT GxP and non-GxP systems ensuring compliance to applicable regulations. Review requirements, specifications, design documents, validation plans and report, user acceptance protocols, test protocols and reports, traceability matrices and other documentation as required and provide feedback. Guiding validation strategies for IT validated systems.. Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation. Support efforts for cybersecurity risk management for both US and ROW requirements. Support development teams on the validation of software tools. Apply knowledge of IT Systems Lifecycles, from Requirements through System Retirement, including Risk Management and Change Control. Salary scale: $126402.00 - $170,400 Requires a Bachelor’s in Engineering, Computer Science, Information Systems or Quality Management /Systems discipline. Higher degree accepted. Plus 60 months post-bachelor’s experience in any job title/occupation performing CSV for GxP software systems including 5 years of experience with guiding Validation Strategies for IT Validated systems including reviewing/resolving issue/defects and/or problem reports, and reviewing performing requirements analysis through lifecycle and documented in Trace Matrices and in GxP Assessments, 21 CFR Part 11 Assessments, Risk Assessments, Validation Plans, Requirements, Functional and Design Specifications, Training, Test Cases, Summary Test and Validation Reports, Issue Logs, Incidence Reports, and Change Management Controls. Email resumes to: Keanu.h.alvarez@insulet.com
