At MilliporeSigma, as the Senior Supplier Quality Engineer, supporting our St. Louis locations, you are responsible for ensuring the quality of raw material used in production of life science products.
You will drive major risk reduction initiatives with suppliers to foster a supplier continuous quality improvement culture.
The desired candidate must be capable of leading supplier audits in accordance with MilliporeSigma and ISO 9001 & ISO 13485 standards.
The Supplier Quality Specialist must have knowledge of root cause methodology, implementation and monitoring of corrective actions with suppliers, and understanding of validation principles and requirements in a cGMP environment.
Lead and manage supplier non-conformances using root cause analysis methods with timely and effective corrective and preventative actions Conduct supplier audits following risk-based auditing strategy to identify quality risk and gapsEffectively partner with suppliers to deploy risk assessments and Failure Mode and Effects Analysis (FMEA) tools to mitigate supplier risk and quality gapsDrive risk mitigation and effective process controls.
Ensure supplier corrective actions are robust and sustainedProvide support to incoming inspection and establish disposition plans for quarantined raw materialAssist in the initiation and maintenance of Supplier Quality AgreementsDrive improvement to overall supply program supplier quality and reliability, supplier auditing, incoming inspection, etc.
Provide sound quality and validation input to supplier qualifications (new suppliers, raw material changes, etc). Ensure all changes follow internal Quality Management System.
change control, CAPA, etc)Maintain standardized metrics that guide actions and promote continuous improvement (e.g. supplier performance, SCAR responsiveness, etc) Who You Are : Basic QualificationsBachelor’s Degree in a scientific discipline (e.
g., Biology, Chemistry, Microbiology, etc.) or a technical discipline (e.g., Computer Science, Data Science, etc. )2 + years’ life science quality experience in a manufacturing setting2 + years’ experience conducting quality audits Preferred QualificationsISO Lead Auditor certification Understanding or experience with ISO & FDA regulations (such as 21 CFR 820, 210 & 211) Travel Requirements : Travel to domestic supplier locations as needed. (
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