Hologic Careers
Lead Risk Management Quality Engineer
Marlborough, MA, United States
Sponsorship not specifiedDetected 8 days ago
Product ManagementFDA RegulatoryMedical Devices
About the role
- 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
Requirements
- If you enjoy influencing systems, shaping strategy, and translating complex risks into clear, data‑driven decisions, this role is for you.
- Strong understanding of FDA Quality System Regulations (21 CFR Part 820 and 860) and ISO 13485. - In‑depth knowledge of industry best practices and emerging trends in risk management processes, tools, and technol...
Apply directly at Hologic Careers →Create a free account for alerts like thisView Hologic Careers immigration profile
This listing is sourced directly from Hologic Careers's careers page and normalized into a canonical job model.