Lead Risk Management Quality Engineer

Marlborough, MA, United States

Hologic’s mission is to enable healthier lives everywhere, every day—and robust risk management is critical to that mission. We’re looking for a **Lead Risk Management Quality Engineer** to ensure the safety and compliance of both on‑market and pre‑market medical devices by serving as the organization’s key risk expert. In this high‑impact role, you’ll lead risk management activities across the product lifecycle, drive improvements to risk processes and procedures, and mentor teams in best‑in‑class risk practices. If you enjoy influencing systems, shaping strategy, and translating complex risks into clear, data‑driven decisions, this role is for you.

Knowledge

+ Deep expertise in **ISO 14971:2019** (Risk Management for Medical Devices) and **EU MDR (2017/745)** risk requirements.
+ Strong understanding of **FDA Quality System Regulations** (21 CFR Part 820 and 860) and **ISO 1348...