Government, Regulatory and Code, Healthcare, Quality, Quality Engineering
Manages the Supplier, Internal, Customer and Regulatory Audit programs.
Assesses/follows suppliers for any purchased products and/or services, in accordance with QMS and Regulatory Requirements.
Assesses the Supplier base on existing and/or potential suppliers in order to control the quality of purchased products and services : defines requirements, perform audits (qualification, follow-up or for cause audits), manages the supplier quality performance assessment and quality control delegation,
Participates to the definition of technical specifications and approves them,
Handles the non-conformities linked with the quality of purchased products in order to request CAPA implementation from supplier side and/or updates the technical specifications,
Participates in the supplier quality meeting with Purchasing, Supply chain and Production departments,
Manages the Supplier, Internal, Customer and Regulatory Audit programs,
Manages Quality Agreements with Suppliers and Customers,
Manages Supplier Quality Notifications and determines impact to process and/or products,
Perform and/or support quality investigation activities, including but not limited to Deviation (Waiver, nonconformity, NCMR) Investigation Reports, CAPA and Complaints
Write, review, and approve Standard Operating Procedures to ensure they comply with the Quality System and current Good Manufacturing Practices,
Initiate and/or oversee change control activities as needed,
Perform any additional job related duties as requested
Bachelor’s Degree with 3-5 years of industry experience or equivalent experience.
Experience in QMS and Regulatory audit management.
CQA or CQE preferred
Skills and Qualifications:
Good knowledge of ISO 9001standards required
Good knowledge of products and processes.
Communication, influencing and negotiation skills.
Willing to travel 10% of the time
Microbiology knowledge is a plus
Work independently and efficiently with little direction
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity
Internal Number: 52127
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!