Working knowledge of FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP
Strong knowledge of root cause analysis tools and ability to lead root cause activities for complaint investigations, NCs, CAPAs, etc.
Ability to appropriately assess written product and project documentation as an advocate for compliance
Hologic's employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities.