Facilitate all Post Market Safety Surveillance meetings and output.
Gathers, reviews, interprets, presents and reports on Post Market Safety Surveillance activities.
Works closely with Product Quality Managers, Medical Safety, Quality Analytics and Customer Relations Staff to develop, review, edit and facilitate timely completion of technical reports and other outputs of Safety Management Team.
Complete monthly trending reports, annual post-market surveillance reports and other monthly and quarterly reports. Participate in various process improvement projects.
Minimum of 3-5 years experience in technical / manufacturing field.
Ability to interpret statistical data required
Technical writing skills required
PC knowledge to include Microsoft office required.
Excellent interpersonal, organizational, oral and written communication skills required.
CAPA and Non-conformance experience preferred.
Experience working in an FDA regulated environment required.
Experience in creating/editing work instructions/procedures preferred.
Document control experience preferred.
SQL knowledge preferred but not required
Corporate / senior
Jacksonville , United States