Perform all work in compliance with company policy and within the guidelines of BioMerieux'sQuality System.2. Establish supplier audit schedules and activities.3. Perform gap analysis of supplier QMS to new and existing regulations and standards.4. Present supplier audit findings at annual Management Review meeting.5. Present supplier audit findings and OFI’s to Supplier Program Manager, and members of Supplier Review Board/Material Review Board.6. Understand company organization, operations, product development cycle and management processes.7. Understand QMS organization and QA functions.8. Maintain supplier audit finding database (SCARs).9. Evaluate supplier audit findings and opportunities for improvement.10. Review supplier audit findings and opportunities for improvement for trends over time. Supplemental Data1. 5-10% Domestic and/or international travel may be required for training purposes.2. 10-20% domestic and/or international travel may be required for performing supplier auditsNote: Travel may be restricted during times of high risk to travelers. Supplier audits may be performed remotely as deemed necessary by management

• Bachelor of Science or Master’s Degree (science, engineering or life sciences). 2. Knowledge of good manufacturing practices, ISO 9001, ISO 13485, and 21 CFR 820 required. 3. 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.4. Knowledge of MDSAP audit program a plus.

Experience1. Minimum 5 years work experience in Medical Device, Pharmaceutical or Biotechnology manufacturing setting that has a formal quality system is required. 2. Auditing experience in Medical Device, Pharma, or Biotechnology industry.

Knowledge, Skills, and Abilities1. Effective written and verbal communication skills2. Proficiency in MS Office tools, including Outlook, Word, and Excel3. General computer operation4. Proficiency in internet navigation5. Attention to detail is fundamental to this position6. Strong organization is required7. Auditing principles and best practices8. Ability to accurately follow and interpret written procedures9. Ability to accurately comprehend and interpret federal and international regulations and standards.10. Excellent communication skills, both oral and written11. Excellent collaboration with cross-departmental leaders within the organization.12. Professional communication and peer-to-peer interactions is a must.13. Critical listening skills 14. Experience with MS Visio a plus15. Ability to prepare clear and concise summaries for executives and stakeholders.16. Strong presentation skills.