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Lead Quality Auditor

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Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Quality

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.

 

Position Summary:

The Lead Quality Systems Auditor is responsible for performing St. Louis site internal audits and ensuring that internal audits comply with applicable procedures, regulations and standards (e.g., 21CFR 820, ISO 13485, ISO 9001, MDSAP). 


Main Accountabilities:

  1. Lead internal quality audits to ensure compliance with applicable procedures, regulations and standards and facilitate continual improvement actions.
  2. Lead internal quality auditor schedules, creates audit plans, executes the audits with assigned auditors, reviews and approves the final audit report and all audit responses and actions. 
  3. Follow up planning of each audit, including: notification of auditees, analysis, recommendation and submittal for approval of the Audit Plan, ensure that Audit Plan has been distributed to auditees, providing assistance to auditors during the steps of preparation.
  4. Act as the facilitator of the audit. 
  5. Ensure audit reports are completed and approved within the required time frame.
  6. Ensure that conclusions of the audit are understood by the auditees.
  7. Ensure that non-conformities and opportunities for improvement are correctly entered into TrackWise, and ensure that all appropriate persons are notified of the non-conformance(s).
  8. Support and review responses and root cause analysis provided for the non-conformities and opportunities for improvement.
  9. Ensure Corrective/Preventive Actions (CAPA) are established and entered into TrackWise as applicable.


Studies, Experience, Skills, and Qualifications:

  • Bachelor's Degree Required
  • Two years of auditing experience required. 
  • Auditing Certification in ISO, CQA, etc. is preferred.
  • Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, MDSAP, etc.)
  • Proficient use of Microsoft Suite
  • TrackWise Enterprise Quality Management Software experience, a plus.
  • Ability to effectively communicate written and orally.

 

Additional Information:

  • Position has typical office setting duties; however walking may be required during area tours.

 

Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!

 

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.

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