Senior Product Quality Engineer
HologicNewark, Delaware, United States
Posted February 2, 2026
97000 - 152700 USD
Full Time
About the Company
Hologic is dedicated to enabling healthier lives everywhere, every dayâand the quality of our on-market medical devices is central to that mission.
Job Description
We're looking for a Senior Product Quality Engineer to lead post-market product quality efforts by driving complaint investigations, root cause analysis, and implementation of corrective and preventive actions.
Requirements
- Working knowledge of FDA Quality System Regulations (21 CFR 820), especially Design Control requirements.
- Familiarity with ISO 13485, EU Medical Device Regulation (MDR), ISO 14971 (Risk Management), GMP, and GDP.
- Strong understanding of root cause analysis tools and their application to complaints, nonconformances (NCs), and CAPAs.
Benefits
- Comprehensive training and continued development and training throughout your career.
- Annualized base salary range: $97,600-$152,700, and is bonus eligible.
