Senior Quality Manager (Engineer)
Location: Saint Louis, United States
Position Type: Unfixed Term
Job Function: Quality
A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.
We are recruiting a Senior Quality Manager for US Supply Chain
You will directly report to the Associate Director Quality for Supply Chain & Product Labeling located in Craponne, France and you will manage a Quality Specialist as one direct report.
What will be your responsibilities at BioMérieux?
Our US distribution network operates 40% of Worldwide deliveries to end customers and 55% of Worldwide total flows.
In the context of a strong development of the US logistics distribution, you will be the single point of contact for Quality Supply Chain in the US and responsible to maintain compliance of Quality System elements applicable to the Supply Chain activities in the US (CAPA, non-conforming products, complaint investigations, auditing, change management, supplier quality, validation, qualification, etc.).
Your main activities will be to :
· Maintain and improve one efficient, robust and sustainable Quality Management System for the International Distribution Center in Saint Louis (IDC STL): KPIs, management review, continuous improvement
· Lead and/or coordinate investigations involving US Distribution Centers (US DCs : IDC STL and subcontracted warehouses) in a timely manner : Non conformities, CAPAs, logistical complaints
· Oversee and back-up operational activities related to temperature analysis during transport for reagents
· Participate to the reverse flows for Equipment and Spare parts (E&S)
· Liaise with our Quality Global Supply Chain teams located in France (IDC St Vulbas and Craponne) and Singapore (Regional Distribution Center ASPAC) as necessary
· Liaise with the US Logistics, US Supply Chain and St Louis site teams to manage activities
· Investigate with the logistic suppliers in case of issues in the US distribution network
· Manage US Freight & Logistics suppliers, assess their performance
· Prepare and support internal and external audit activities related to the US DCs
· Ensure inspection readiness and continuous improvement
· Participate to strategic projects for the Supply Chain in the US and ensure their compliance to regulations and standards
Who are you?
Studies and Experience:
·Bachelor's Degree required with a minimum of 7 years of experience working as a Quality Manager or Engineer.
Skills and Qualifications:
· Demonstrated competence in the selection and use of Quality Engineering tools, techniques, and processes.
· Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO 13485, QSR-21 CFR, IVDR, MDSAP, etc.).
· Certified Quality Engineering (CQE), Certified Quality Auditor (CQA) or Six Sigma Black Belt desired
· Your team management skills, your leadership, your pragmatism, your ease in working in the field, as well as strong communication and negotiation skills will succeed in this position
Please be aware that recruitment related scams are on the rise. Fraudulent job postings are being placed on other websites, and individuals posing as bioMérieux Talent Acquisition team members are reaching out via email or text message in an attempt to collect your personal and confidential information. In some cases, these scammers are also conducting bogus interviews prior to extending fraudulent offers of employment. Beware of individuals reaching out using general phone numbers and non-bioMerieux email domains (i.e. Hotmail.com, Gmail.com, Yahoo.com, etc.). If you are concerned that an interview experience or offer of employment might be a scam, please make sure you are searching for the posting on our careers site https://careers.biomerieux.com/ or contact us at [email protected].
BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).
