Clinical QA Specialist

Newark, DE, United States

Marlborough, MA, United States

Are you passionate about ensuring compliance and patient safety in the medical device industry? At Hologic, we are seeking a **Clinical QA Specialist** to play a critical role in the investigation and reporting of potential and actual adverse events, as well as other regulatory reporting activities. In this role, you’ll collaborate with cross-functional teams, including Technical Service, Marketing, Sales, and Regulatory, to ensure timely and thorough documentation, analysis, and reporting. If you thrive in a fast-paced, collaborative environment and have a strong background in regulatory compliance and quality assurance, this is your opportunity to make a meaningful impact on healthcare innovation.

**Knowledge:**

+ Comprehensive understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 for risk management.
+ Stron...