Senior Software Quality Assurance Engineer

Andover, MA Contract Job Description 10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred) Strong hands‑on experience with design controls, DHF management, and traceability in regulated environments Working knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304) Experience supporting software quality within the SDLC and understanding of software risk management principles Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes