Carole Morley
About Carole Morley
Carole Morley is the Senior Manager of Product Complaints for the Endoscopy and Urology Divisions at Boston Scientific, with extensive experience in quality and risk management within the healthcare industry.
Current Role at Boston Scientific
Carole Morley is currently the Senior Manager of Product Complaints for the Endoscopy and Urology Divisions at Boston Scientific. She has held this position since 2018. In this role, she oversees the handling and resolution of product complaints, ensuring compliance with regulatory standards and enhancing product quality and customer satisfaction. The position is based in Marlborough, Massachusetts.
Previous Experience at Boston Scientific
Before her current role, Carole Morley served as the Manager of Post Market Surveillance at Boston Scientific from 2009 to 2018. In this capacity, she managed product complaints across Endoscopy, Urology, and Women's Health divisions. Her responsibilities included monitoring and analyzing product performance and implementing corrective actions to maintain compliance with regulatory requirements.
Educational Background
Carole Morley earned her MBA from Benedictine University. Additionally, she holds a Bachelor's Degree from the University of Illinois at Chicago, specifically from the College of Nursing. These educational qualifications have provided her with a strong foundation in both business management and healthcare, essential for her roles in quality and risk management.
Expertise in Regulatory Compliance
Carole Morley has expertise in managing product complaints in compliance with FDA 21 CFR Part 803 and EU 2017/745 MDR regulations. This involves rigorous documentation, investigation, and reporting processes to meet stringent regulatory standards. Her knowledge ensures that Boston Scientific remains compliant with both U.S. and European medical device regulations.
Experience in Quality and Risk Management
Carole Morley possesses extensive experience in quality and risk management within hospital settings. This experience has been instrumental in her ability to oversee complex projects related to the healthcare and medical device industries. Her background supports her proficiency in identifying and mitigating risks associated with product complaints and market surveillance.