The Position:

As the Quality Manager, Supplier QA you will lead the qualification, monitoring, and oversight of Veracyte’s Contract Manufacturers (CMOs) and IVD suppliers. You will serve as the primary quality interface between Veracyte and its external manufacturing partners, ensuring that all products and processes meet applicable regulatory requirements (e.g., ISO 13485, FDA QSR, IVDR) and internal quality standards. The ideal candidate brings strong supplier quality experience, auditing, and managing external manufacturing relationships. This is a hybrid role (remote and in office up to 3 days a week as necessary) and is based out of our headquarters in South San Francisco (SSF), California, United States.

Responsibilities:

• Own and lead the Supplier Quality Management to ensure vendor products, processes and services are provided in compliance with applicable regulations (e.g., FDA, ISO 13485, EU IVDR, etc.) and Veracyte’s quality standards.
• Establish and maintain supplier and CMO oversight strategies, including risk-based qualification, periodic performance monitoring, and quality metrics.
• Serve as the primary Quality lead for supplier and CMO relationships, providing quality input during supplier selection, qualification, and issue resolution.
• Lead and execute supplier audits, ensure timely closure of audit findings, and drive continuous improvement across the supplier base.
• Develop, implement, and maintain supplier quality metrics and monitoring programs.
• Lead investigations of supplier and CMO related quality incidents, perform root cause analysis, assess impact on product or regulatory compliance
• Oversee and maintain the Approved Supplier List (ASL) and associated supplier documentation in compliance with ISO 13485 and IVDR.
• Lead suppliers and CMOs qualification activities, including risk assessments, audits, and quality agreements
• Issue, track, and close Supplier Corrective Action Requests (SCARs) related to supplier non-conformances
• Review and approve supplier change notifications and deviations to assess the impact on product quality and regulatory compliance.
• Ensure appropriate validation and verification activities are performed for supplier-initiated changes
• Collaborate cross-functionally with R&D, Regulatory Affairs, and Supply Chain to support new product introductions and design transfers to CMOs.
• Support regulatory inspections and notified body audits, serving as the SME for supplier quality.
• Champion continuous improvement initiatives to strengthen supplier quality processes and reduce external quality risk.

Who You Are:

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field
• A minimum of 6 - 7 years of progressive experience in Quality Assurance within the medical device or IVD industry.
• In‑depth working knowledge of in‑vitro diagnostic device quality requirements, including ISO 13485:2016, IVDR (EU 2017/746) and, ISO 14971:2019 risk management
• Prior experience in implementing and establishing a Supplier Quality program that is compliant to ISO13485 and IVDR requirements
• Demonstrated success in supplier quality leadership, audit execution, and external manufacturing oversight.
• Willingness to travel (up to ~30%) to supplier and CMO sites.
• Strong written and verbal communication skills; demonstrated ability to author clear SOPs, technical documents, and audit responses
• Strong organization skills to manage multiple simultaneous projects in a fast-paced environment.
• Attention to detail in understanding and documenting complex quality issues
• Highly organized, self-motivated, and comfortable working in a fast-paced IVD environment.
• ISO 13485 Lead Auditor or equivalent lead auditor certificate is preferred

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