Quality Assurance Engineer 2

Newark, DE, United States

Join Hologic as a **Quality Engineer** in a regulated medical device environment, responsible for ensuring products, processes and systems meet internal quality requirements and external regulatory standards (e.g., FDA, ISO). The position supports Operations, Engineering and R&D, focusing on defect prevention, continuous improvement, and robust manufacturing practices.

**Knowledge**

+ Quality Management Systems (QMS) for medical devices
+ GMP, GDP principles and basic regulatory frameworks
+ Medical device Quality System Regulations (21 CFR 820), ISO 13485, MDD (beneficial)
+ Risk management, risk assessments and documentation updates
+ Nonconformance (NCE), CAPA, SCAR, MRB processes
+ Inspection, testing and validation methods for products and processes
+ Statistical analysis and scientific method (beneficial)
+ Basic understanding of microbiology, molecular biology, biochem...