Biomerieux , Inc.
Lead Quality System Auditor
At a glance
Location: US-MO-St. Louis, MO, United States Map
Posted: 11/19/2019
Closing: 12/18/2019
Degree: 4 Year Degree
Type: Full-Time
Experience: 3 to 4 years
Biomerieux , Inc.
Job description
World leader in the field of in vitro diagnostics for over 55 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety.

bioMérieux is present in 43 countries and more than 160 countries with the support of a large network of distributors. Its corporate headquarters are located in Marcy l'Etoile, near Lyon, in France.

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.

We look for candidates whose motivation is to invest in themselves, in the projects of the future, and to participate in a collective adventure led by a pioneering spirit.

We have the commitment to offer our collaborators a working environment which encourages team spirit, with priority given to training and development with international career opportunities.

World leader in the field of in vitro diagnostics for over 50 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety.

bioMérieux is present in over 150 countries through 43 subsidiaries and a large network of distributors. More than 90% of our sales are done internationally. Its corporate headquarters are located in Marcy l'Etoile, near Lyon, in France.

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.

We look for candidates whose motivation is to invest in themselves, in the projects of the future, and to participate in a collective adventure led by a pioneering spirit.

We have the commitment to offer our collaborators a working environment which encourages team spirit, with priority given to training and development with international career opportunities.

Our Group offers numerous possibilities: so come and join the 10,000 bioMérieux employees who have already identified with these values!

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).

Leads internal quality audits to ensure compliance with applicable procedures, regulations and standard and to facilitate continual improvement actions.
Lead internal quality auditor schedules audits, creates audit plans, executes the audits with assigned auditors, reviews and approves the final audit report and all audit responses and actions.
Uses well developed verbal and written communication and interpersonal skills to facilitate negotiation, mediation, conflict resolution and report writing during the course of the audit.

Duties include:
* 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.
* Interfacing between auditors and auditees. Acts as the facilitator of the audit.
* Ensure the completion of the audit. Ensure audit reports are completed and approved within the required time frame.
* Ensure that conclusions of the audit are understood by the auditees.
* 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).
* Support and review responses and root cause analysis provided for the non-conformities and opportunities for improvement.
* Ensure Corrective/Preventive Actions (CAPA) are established and entered into TrackWise as applicable.

KNOWLEDGE AND EXPERIENCE:
* Bachelors Degree with 3+ years industry experience or equivalent experience in related industry.
* Two years of auditing experience required.
* Auditing Certification is desired (ISO, CQA, etc)
* Ability to effective communicate written and orally.
* Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, MDSAP, etc.)
* Experience in the use of computers and applicable software (MS Windows, MS Office)
* TrackWise Enterprise Quality Management Software experience a plus.
* Ability to multitask, adhere to strict deadlines and manage multiple priorities.

bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity.
Lead Quality System Auditor