California Licensed Clinical Quality Manager

Job Summary

Providing clinical guidance and expertise, the full-time Senior Manager, Clinical Product Quality will manage complaint handling and post-market surveillance for medical devices, ensuring thorough investigation of product complaints and health risks while working remotely from within the United States.

Key responsibilities:

• Provides medical/clinical guidance to complaint investigators on event interpretation and investigation
• Analyzes and interprets complaint data for product lines and regulatory submissions
• Educates and trains complaint investigators and cross-functional teams on patient anatomy and medical conditions

Required qualifications:

• Bachelor's degree plus 10 years of relevant experience or equivalent work experience
• Current or expired Registered Nurse (RN) license
• Cardiac patient care experience in settings such as ICU, OR, or cardiovascular interventions
• Experience in the medical device industry related to Quality/Compliance, especially in complaint handling
• Strong understanding of FDA's Quality System Regulations and medical device regulations