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.
Come be a part of our team and our mission as a Quality Auditor!
Principal Job Duties and Responsibilities:
- Perform all work in compliance with company policy and within the guidelines of BioFire Diagnostics’ Quality System
- Understand company organization, operations, product development cycle and management processes
- Understand QMS organization and QA functions
- Help establish annual internal audit schedules and activities
- Perform internal audits according to annual schedule.
- Perform gap analysis of QMS to new and existing regulations and standards (as needed)
- Provide audit findings for Management Review report and meeting
- Evaluate FDA 483, and other regulatory finding, trends
Minimal domestic travel may be required for training purposes
Training and Education:
- Bachelor of Science or Master’s Degree (science, engineering or life sciences).
- Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and 21 CFR 820 required
- Knowledge of quality principles and regulations applicable to in vitro diagnostic products, including FDA QSR, ISO 13485, CMDR, CE Marking, ISO 9001, ISO 14971, In Vitro Diagnostic Directive/In Vitro Diagnostic Regulation.
- Knowledge of MDSAP audit program a plus
- Minimum 5 years work experience in Medical Device, Pharmaceutical or Biotechnology manufacturing setting that has a formal quality system is required.
- Auditing experience in Medical Device, Pharma, or Biotechnology industry
- Effective written and verbal communication skills
- Proficiency in MS Office tools, including Outlook, Word, and Excel
- General computer operation
- Proficiency in internet navigation
- Attention to detail is fundamental to this position
- Strong organization is required
- Auditing principles and best practices
- Ability to accurately follow and interpret written procedures
- Ability to accurately comprehend and interpret federal and international regulations and standards
- Excellent communication skills, both oral and written
- Excellent collaboration with cross-departmental leaders within the organization
- Professional communication and peer-to-peer interactions a must
- Critical listening skills
- Experience with MS Visio a plus
- Ability to prepare clear and concise summaries for executives and stakeholders
- Strong presentation skills
Must be able to sit or stand for moderate amounts of time and look at computer monitors for an extended amount of time with or without accommodation.