Postmarket Surveillance Specialist III

3 weeks ago


Salt Lake City, United States BioFire Diagnostics, LLC. Full time

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



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