Postmarket Surveillance Specialist III

3 weeks ago


Salt Lake, Utah, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

Description

Essential Job Duties and Responsibilities

  • Perform all work in compliance with company policy and within the guidelines of BioFires 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 EducationBachelors 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 fields concepts, practices, procedures, rules and regulations.
  • Knowledge of medical device regulation preferred
Physical RequirementsPhysical requirements found in a typical office setting

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