Job Description
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...
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...