Biomerieux , Inc.
Supplier Quality Manager
At a glance
Location: US-MO-United States, United States Map
Posted: 10/21/2019
Closing: 11/20/2019
Degree: 4 Year Degree
Type: Full-Time
Experience: 10 to greater than 15 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 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 services 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.

Our Group offers numerous possibilities: so come and join the 11,200 bioMérieux employees who have already identified with these values!

This position is responsible for managing the supplier quality audit program within Quality and ensuring the supplier quality program is correctly tied to manufacturing and product risks. Responsibilities will include improving how the supplier quality program is used to drive quality into bioMerieux products and manufacturing processes. Considerations for supplier quality, capability, corrective actions, cost, and bioMerieux/supplier quality oversight must be formally analyzed to ensure appropriate suppliers are selected and monitored.

The incumbent will lead and work closely with Suppliers, Global Purchasing, Supply Chain, Industrialization, Manufacturing and Engineering in the improvement and management of the supplier quality program. This employee will interact cross functionally with all levels of the BMX organization and drive improvement in the Suppler Quality program.

* Maintains compliance of Quality System elements applicable to the Site/Function (Supplier Audits, Focused Audits, Supplier Quality Management, Supplier Change Control)
* Manages inquiries related to Supplier Quality
* Manages the Supplier Corrective Action program to ensure suppliers meet performance requirements in quality and service
* Ensures Supplier Quality Program considers Risk to bioMerieux manufacturing and final products with applicable supplier oversight.
* Leads or facilitates team to accomplish deliverables and provides appropriate team support in cross functional audits, projects and activities.
* Maintains compliance to quality standards for all new and existing products .
* Evaluates prospective suppliers ensuring capabilities and systems align with established requirements.
* Evaluates and reviews supplier quality agreements with Legal and Purchasing to ensure agreements align with established Company requirements.
* Manages suppliers to assure applicable systems are in place for the identification, processing and disposition of non-conforming materials provided by suppliers of non-conforming materials provided by suppliers.
* Partners with Engineering, Manufacturing , Supply Chain and Suppliers for effective material life cycle management
* Recruits, trains and develops personnel, establishes resources and determines actions necessary to accomplish Site Quality Objectives.

\

* Bachelors degree in science or engineering with >10 years of relevant industry GMP experience including at a minimum 3 years supervisory experience preferred.
* Expertise in FDA-Quality System Regulation, Canadian-Medical Device Registration, IVD Directive and other applicable country specific regulations) and applicable standards (ISO-9001:2000 & ISO 13485, etc.)
* Effective leadership and communication skills.
* Expertise in conducting quality supplier audits and supporting regulatory inspections.
* Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), or Certified Biomedical Auditor (CBA) desired.
* Experience using software tools for trending and analysis.
* Advanced technical writing skills.
* >5 years experience with supplier quality/qualification and experience in building supplier quality programs
* Understand manufacturing processes as it relates to supplier provided materials
* Experience facilitating quality supplier reviews
* Knowledge/experience with risk management preferred.
* A solid understanding of the potential sources of supplier quality risk and how to manage risk in a manufacturing environment
* Skilled in collaborating with multi-disciplinary teams
* Master problem solver / decision maker
*
*
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity
Supplier Quality Manager