Job Information
BIOMERIEUX, INC. Postmarket Surveillance Specialist III in SALT LAKE CITY, Utah
Description Essential Job Duties and Responsibilities * Perform all work in compliance with company policy and within the guidelines of BioFire's Quality System. * Follows laws and regulations applicable to Postmarket Surveillance. * Conducts, reviews and closes complaint investigations within the Complaint Investigation software tool according to processes. * Conducts and reviews escalated complaints for potential reportable events. * Coordinates with regulatory affairs to complete reportable event documentation. * Review trend charts and perform data analysis. * Work with experts from other departments during investigation process. * Review complaints for CAPA. * Conduct product literature review and work with other departments to address product performance in the field. * Perform weekly statistical performance review to monitor manufactured product. * Ensure trends are reported to the Postmarket surveillance management. * Ensure PSS I and II are adequately trained and prepared to handle complaints associated with new products before they are released for distribution to the field. * Assess in the development and improvements of the current Post Market Surveillance processes and work with management to identify problem areas and implement solutions. * Coordinates input on data from other functional teams. * Supports and performs level II job duties as needed. * Performs other duties as assigned Qualifications Training and Education
Bachelor's degree in Scientific Field. Experience * 5 year of laboratory experience and troubleshooting molecular tests. Microbiology or clinical lab experience is preferable. * Film Array experience preferred Knowledge, Skills and Abilities * Detail oriented * Organizational skills * Data analysis * Effective writing and communication skills * Time management * Analytical skills * Ability to work independently * Ability to follow detailed processes * Strong knowledge of the clinical molecular diagnostic field's concepts, practices, procedures, rules and regulations. * Knowledge of medical device regulation preferred Physical Requirements
Physical requirements found in a typical office setting