Software Quality Engineer – Design Assurance

Job Title: Software Quality Engineer Design Assurance Location: Massachusetts (Onsite) Experience: 7+ years strongly preferred Job Description Seeking a Software Quality Engineer to provide independent Quality oversight throughout the software development lifecycle (SDLC). Responsibilities include reviewing Design History File (DHF) documentation, ensuring regulatory compliance, and supporting risk analysis, change control, and project meetings. Required Skills Knowledge of 21 CFR Part 820, 21 CFR Part 11, ISO 13485, ISO 14971, IEC 62304, and IEC 62366-1. Understanding of software quality, SDLC, cybersecurity, and privacy requirements. Regulated industry experience; medical device experience preferred. R&D or software V&V candidates may be considered if they understand the full SDLC.