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Postmarket Surveillance Specialist III

Location: Salt Lake City, UT, United States
Position Type: Unfixed Term
Job Function: Regulatory Affairs

Description

Come be a part of our team and our mission

At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.

We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.

The Postmarket Surveillance Specialist III (PSS-III) is responsible to conduct, review, and close complaint investigations. This position will work with management in enhancing the complaint investigation closure time and process. The PSS-III supports and helps in troubleshooting the product, identifies trends, and problem areas as they arise. The PSS-III will support Postmarket management in improving internal processes KPI’s, literature review process, and product trending and performance in the field. 

Essential Job Duties and Responsibilities

  1. Perform all work in compliance with company policy and within the guidelines of BioFire’s Quality System.
  2. Follows laws and regulations applicable to Postmarket Surveillance.
  3. Conducts, reviews and closes complaint investigations within the Complaint Investigation software tool according to processes.
  4. Conducts and reviews escalated complaints for potential reportable events.
  5. Coordinates with regulatory affairs to complete reportable event documentation.
  6. Review trend charts and perform data analysis.
  7. Work with experts from other departments during investigation process.
  8. Review complaints for CAPA.
  9. Conduct product literature review and work with other departments to address product performance in the field.
  10. Perform weekly statistical performance review to monitor manufactured product.
  11. Ensure trends are reported to the Postmarket surveillance management.
  12. 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.
  13. Assess in the development and improvements of the current Post Market Surveillance processes and work with management to identify problem areas and implement solutions.
  14. Coordinates input on data from other functional teams.
  15. Supports and performs level II job duties as needed.
  16. Performs other duties as assigned.

 

Supplemental Data

N/A

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

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.

Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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