Quality Assurance Specialist - Supplier Quality

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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.

• 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.
• Collaborate 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.

Who You Are:

Minimum Qualifications:

• 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

OR

• High School Diploma or GED with 8+ years of experience in a Quality role within the life science or IVD (medical) industry

Preferred Qualifications:

• 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