Medical Device Quality Engineer

Our client, a leading medical device organization, is seeking a Senior Software Quality Assurance Engineer to join their team. As a Senior Software Quality Assurance Engineer, you will be part of the Quality Engineering department supporting Product Development and Software Engineering teams. The ideal candidate will have strong analytical skills, attention to detail, and cross‑functional collaboration abilities which will align successfully in the organization. Job Title: Medical Device Quality Engineer Location: Andover, MA (Hybrid – 3 days onsite) Pay Range: $57/hr (W2) Duration: 3‑Month Contract‑to‑Hire (Potential for full‑time conversion based on performance) What’s the Job? Lead design quality activities across the full product lifecycle, ensuring compliance with design controls Maintain DHF, DMR, and DHR documentation with full traceability Perform risk management activities including FMEA and hazard analysis Provide oversight of software SDLC aligned with IEC 62304 standards Support verification, validation, audits, and regulatory compliance efforts What’s Needed? 10+ years of experience in medical device quality engineering (Class II/III preferred) Strong expertise in design controls, DHF management, and traceability Knowledge of 21 CFR 820, ISO 13485, ISO 14971, and IEC 62304 Experience with software quality within SDLC and risk management techniques Experience with CAPA, audits, and quality systems (eQMS/PLM) What’s in it for me? Opportunity to work on cutting‑edge medical device technologies Exposure to end‑to‑end product lifecycle and regulatory processes Hybrid work flexibility (3 days onsite) Collaborative, cross‑functional work environment Potential for contract‑to‑hire conversion If this is a role that interests you and you'd like to learn more, a recruiter will be in touch with you to discuss this opportunity. We look forward to speaking with you! #J-18808-Ljbffr