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 & 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