Job Opening – Quality Specialist II

BioFire Defense is an Equal Opportunity Employer (M/F/D/V).


Quality Specialist II Posted: 12/04/2020



Full-Time Quality Assurance

Position Summary:

  • This is a full-time, non-exempt position. This individual is responsible for administration and completion of activities related to the Quality Management System (QMS). Primarily, this individual will be responsible for providing support to the Corrective and Preventive (CAPA) system and the supplier program, maintaining QMS metrics and data, assisting in QMS reviews and process improvements, performing system audits and reviews to established standards and regulations, and any other responsibilities as directed by QA managers and BioFire Defense operating procedures.
  • This position regularly interacts and/or collaborates with other departments, within BioFire, in the execution of their duties. This position follows standard work practices and procedures and must operate in accordance with FDA, OSHA, ISO, and applicable government regulations and standards. This individual is expected to work independently or cooperatively with little to no supervision in the completion of assigned tasks.


Training and Education:

  • College degree preferred. High School diploma with experience is acceptable.
  • Excellent computer skills, including advanced proficiency in MS Word, Excel, and PowerPoint.
  • ISO Lead Auditor Training preferred, but may be acquired on the job.



  • 2 years of formal Quality System experience (e.g., ISO 9000 or GMP/ISO 13485 Quality System) including experience in audit activities preferred.
  • 1+ years of medical device laboratory experience, or a degree in scientific, technical writing, or Quality discipline preferred.



  • We offer competitive salaries
  • Matching 401k
  • Vacation/holiday pay
  • Medical benefits
  • Stimulating work environment

If you are interested in this position please send us your resume and contact details through one of our job boards at:

Click on the job board of your preference.  

Our EEO Policy

BioFire Defense is an equal opportunity employer (M/F/D/V). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.