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.
Ensure products and services received from suppliers meet the quality standards of bioMerieux. Work closely with Suppliers, Global Purchasing, Supply Chain, Industrialization, Manufacturing and Engineering in the execution of the supplier quality program. Provide quality support in the areas of SCAR management, supplier change control, supplier management, and supplier qualification to ensure compliance with the FDA and other regulatory requirements.
1. Maintain compliance of Supplier Quality System elements applicable to the Site/Function (Supplier Audits, Focused Audits, Supplier Quality Management, Supplier Change Control)
2. Manage relationships and key metrics for suppliers.
3. Participate in regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of supplier quality.
4. Create and manage the supplier audit program including; audit plan, scheduling, audit execution, writing audit report and follow up on corrective actions as needed.
5. Monitor supplier performance and report Quality Indicator data during appropriate Supplier Steering Committee meetings.
6. Issue Supplier Non-Conformance documents as needed, tracks responses, and verifies corrective actions.
7. Act as Principle Quality contact at Supplier Steering Committee meetings and Business Reviews providing information and metrics.
8. Act as Change Review Board participant and Quality reviewer/approver for change management activities.
9. Manage supplier change notifications by tracking, evaluating, and coordinating (when necessary) technical assessments, drawing/document updates and SAP updates due to supplier changes.
10. Obtain Supplier Quality Agreements when applicable.
11. Participate and provide guidance for Supplier change checklist process.
12. Provide supplier quality metrics as needed for company meetings (including weekly, monthly, quarterly and QSMR).
13. Assist with the approval / disapproval of suppliers, including collaboration with the purchasing group on supplier leveling and
14. Support continuous improvement projects.
15. Conduct and/or approve investigations as needed (NCs and CAPAs)
Studies, Experience, Skills and Qualifications:
1. Requires a Bachelors degree in a scientific field.
2. Requires a minimum of 4 years related experience with competence in the selection and use of Quality Engineering Tools and Techniques and experience in auditing.
3. Requires strong computer skills in Microsoft Office Package (Excel, Word, etc.).
4. Must possess strong written and verbal communication skills.
5. Must have a knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (ISO, QSR, UL, CSA, VDE, etc.).
6. Certification in one of the following is highly desired: CQE, CSQE, CRE, CQA, CBA, or Six Sigma Green Belt.
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.