- 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
- 5 year of laboratory experience and troubleshooting molecular tests. Microbiology or clinical lab experience is preferable.
- Film Array experience preferred
- 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
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Postmarket Surveillance Specialist III - Salt Lake City, United States - Biofire Diagnostics
Description
Essential Job Duties and ResponsibilitiesTraining and Education
Bachelor's degree in Scientific Field.
Experience
Physical requirements found in a typical office setting
