Quality Assurance Specialist - Supplier QualityMerck Group • Saint Louis, MO, US
Quality Assurance Specialist - Supplier Quality
Merck Group • Saint Louis, MO, US
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job_description.job_card.job_descriptionCollaborate with R&D, Procurement, and Manufacturing to define supplier selection criteria and ensure new suppliers are qualified according to established procedures. Develop and maintain Approved Supplier Lists (ASL) and associated documentation. Establish and monitor key performance indicators (KPIs) for supplier quality, including defect rates, on-time delivery, and responsiveness to issues. Conduct regular supplier performance reviews and provide feedback to suppliers. Issue, track, and close Corrective and Preventive Actions (CAPAs) and Supplier Corrective Action Requests (SCARs) related to supplier non-conformances. Work closely with suppliers to implement robust root cause analysis and effective corrective actions for quality issues. Perform and support supplier risk assessments for critical components and materials, identifying potential failure modes and developing mitigation strategies. Ensure suppliers have robust risk management processes in place that align with IVD product safety and efficacy. Review and approve supplier change notifications to assess the impact on IVD product quality and regulatory compliance. Ensure appropriate validation and verification activities are performed for supplier-initiated changes. Collaborate with R&D during product design and development to ensure supplier capabilities meet design requirements and specifications for new IVD products. Support the selection of critical components and materials from qualified suppliers. Support internal and external audits (e.g., FDA, Notified Body) related to supplier quality and provide necessary documentation and evidence. Ensure all supplier quality activities are compliant with FDA 21 CFR Part 820, ISO 13485, IVDR (EU 2017 / 746), and other relevant international IVD regulations and standards. Maintain accurate and complete supplier quality records. Drive continuous improvement initiatives with suppliers to enhance quality, reduce costs, and improve efficiency. Develop and deliver supplier quality training as needed. Bachelor's Degree in Engineering (Chemical, Biomedical, etc.) or Life Science (Chemistry, Biology, etc.) with 2+ years of experience in a Quality role within the life science or IVD (medical) industry High School Diploma or GED with 8+ years of experience in a Quality role within the life science or IVD (medical) industry Proven experience conducting supplier audits and managing supplier corrective actions Strong understanding of quality tools and methodologies (e.g., Root Cause Analysis, FMEA, SPC, Six Sigma, Lean principles) Excellent communication, interpersonal, and negotiation skills, with the ability to effectively interact with suppliers and internal stakeholders at all levels Strong problem-solving and analytical abilities with a keen attention to detail Ability to work independently and collaboratively in a fast-paced environment Proven ability to manage multiple projects and priorities simultaneously Willingness and ability to travel up to 10% (domestic) for supplier audits and meetings
Job Description
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 :
The Supplier Quality Specialist for IVD Products will be a critical member of our Quality team, responsible for ensuring the quality and reliability of components, materials, and services received from external suppliers used in the design, development, and manufacturing of our In Vitro Diagnostic products. This role requires a deep understanding of IVD regulations (e.g., FDA 21 CFR Part 820, ISO 13485, IVDR), risk management, and supplier management best practices. The Supplier Quality Specialist will drive continuous improvement initiatives with suppliers to enhance product quality, reduce defects, and ensure compliance with all applicable quality system requirements and regulatory standards.
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- Lead and participate in supplier evaluations, audits, and assessments (on-site and remote) to determine their capability to meet our quality, regulatory, and technical requirements for IVD products.
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Who You Are :
Minimum Qualifications :
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Preferred Qualifications :
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Pay Range for this position - $66,800 to $109,300 / year
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here .
RSREMD
What we offer : We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
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Quality Assurance Specialist • Saint Louis, MO, US
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