Assoc I Quality Product Surveillance
Core
Manage customer complaints and Medical Device Reports (MDRs) to ensure product quality and regulatory compliance.
Role type
Associate I Quality Product Surveillance (Medical Device)
Builds
Post-market surveillance activities and regulatory reporting
Domain
Medical Device / Healthcare
Required skills
complaint management, MDR preparation, regulatory compliance, cross-functional collaboration, customer communication, workflow monitoring, sample retrieval coordination, continuous improvement, mentorship
Preferred skills
Project Management, clinical certifications (Medical Technologist, RN, etc.), Bachelor's degree
Technologies
complaint management systems
Responsibilities
Manage and process customer complaints and MDRs; Open, document, and maintain complaint records; Gather and assess complaint information; Evaluate complaints for reportability and prepare regulatory submissions; Support complaint investigations and sample retrieval; Communicate with customers regarding complaint status; Ensure timely completion and closure of complaint records; Monitor workflow and escalate concerns; Coordinate internal and external communications; Participate in continuous improvement initiatives; Provide guidance and training to less experienced team members
Seniority
Associate I, hands-on IC