Anita Homco

Senior Quality Systems Specialist, Orthopaedic Product Montoring @Viant Medical

Fort Wayne, IN, US

Responsible for driving all complaint investigation activities with cross functional team members and approving of complaint investigation reports and a champion in ensuring timely closure of complaints investigations to comply with FDA requirements and other regulatory bodies and countries.+ Interfaces with customers to gather additional information required for complaint investigation and prepares customer communications, with a high level of professionalism.+ Leads and assists with the execution of Viant Post Market Surveillance Reviews, and ensures Post Market activities are being performed per the required timelines.+ Responsible for assessing Adverse Event reportability decisions in accordance with US and International regulations and the completion, submission and review of applicable reports to applicable agencies.+ Track and trend complaints, including provision of trend reviews / reports to customers, site and corporate management, Post Market Surveillance Reviews and Research & Development support.+ Responsible for driving completion and documentation of product issue risk assessments at a high level of technical rigor or accuracy.+ Responsible for regulatory notification or market correction activities (i.e. field alert / recall activities) as directed by Field Action Committee.+Represents Viant as subject matter expert for complaints, Post Market Surveillance and Medical Device Reporting during audits.+ Provides direction and guidance related to complaint handling, Post Market Surveillance and Medical Device Reporting to others as needed.+ Assists with quality management initiatives and objectives including writing procedures and work instructions as required.

Indiana Wesleyan University

Business Administration, Management and Operations