Sr. Quality Assurance Specialist - Supplier Quality

 

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

 

Your Role: 

 

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 gaps
• Effectively partner with suppliers to deploy risk assessments and Failure Mode and Effects Analysis (FMEA) tools to mitigate supplier risk and quality gaps
• Drive risk mitigation and effective process controls. Ensure supplier corrective actions are robust and sustained
• Provide support to incoming inspection and establish disposition plans for quarantined raw material
• Assist in the initiation and maintenance of Supplier Quality Agreements
• Drive 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 Qualifications

• Bachelor’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 setting
• 2 + years’ experience conducting quality audits

 Preferred Qualifications

• ISO 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. (<5%)
• Strong written and verbal communication skills
• Ability to operate in a fast-paced environment
• Ability to problem solve and make decisions
• Ability to work in a team environment

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to