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