Quality Assurance Manager Opportunity - Hologic, Inc. - (Marlborough, MA)

The Post Market Surveillance Manager will oversee all activities related to the complaint handling process. The Manager will provide direction to individuals who receive and investigate product complaints, evaluate returned products, and perform data analysis. They will follow established global regulations for complaint handling and prepare and assemble complaint info for regulatory inquiries and management review. This person will provide support during inspections by regulatory bodies, ensure appropriate and timely global medical device reporting, and monitor for trends in product complaints. - Oversee Complaint processing in compliance with FDA Quality System Regulation, 21 CFR Part 820. - Conduct and Review Health Hazard Risk assessments as assigned in conjunction with Design Assurance. - Manage the timely in-flow of customer complaints, the assignment of investigation responsibilities, and expedient processing and closure.