Quality Engineer, Design Control
HologicSan Diego, California, United States
Posted November 20, 2025
78300 - 122400 USD year
Full Time
About the Company
Hologic is committed to making women's health a priority.
Job Description
As a Quality Engineer in our Design Quality team, you will play an integral role in supporting quality activities related to Design Control efforts in accordance with FDA, ISO, and other IVD regulations.
Requirements
- Bachelor's degree in engineering or a life science discipline or equivalent
- Minimum of 2 – 5 years of experience, specific to design control/quality product design experience in a regulated environment, ideally in the IVD space
- Working knowledge of Quality Management System for Medical Device Manufacturing FDA 21 CFR 820, ISO 13485 as well as CE mark requirements, In Vitro Diagnostic Regulation (EU) 2017/746 and Medical Device Regulation (EU) 2017/745, Risk Management ISO 14971, and other applicable quality and regulatory standards
Benefits
- PTO
- Employee Stock Purchase Plans
- Employee Wellness plans