Sr. Quality Specialist, Supplier QA

At Veracyte, we offer exciting career opportunities for those interested in joining a pioneering team that is committed to transforming cancer care for patients across the globe. Working at Veracyte enables our employees to not only make a meaningful impact on the lives of patients, but to also learn and grow within a purpose driven environment. This is what we call the Veracyte way – it’s about how we work together, guided by our values, to give clinicians the insights they need to help patients make life-changing decisions. 

Our Values:

• We Seek A Better Way: We innovate boldly, learn from our setbacks, and are resilient in our pursuit to transform cancer care
• We Make It Happen: We act with urgency, commit to quality, and bring fun to our hard work
• We Are Stronger Together: We collaborate openly, seek to understand, and celebrate our wins
• We Care Deeply: We embrace our differences, do the right thing, and encourage each other

 

The Position:

As a Senior QA Specialist, Supplier QA you will be responsible for the qualification, monitoring, and oversight of Veracyte’s Contract Manufacturers (CMOs) and IVD suppliers. You will partner closely with internal stakeholders and external manufacturing partners to ensure products are manufactured in compliance with applicable regulations (e.g., FDA, ISO 13485, EU IVDR, etc.) and Veracyte’s 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 at least 3 days a week) and is based out of our headquarters in South San Francisco (SSF), California, United States.

Responsibilities:

 

• Partner closely with internal stakeholders and external manufacturing partners to ensure products are manufactured in compliance with applicable regulations (e.g., FDA, ISO 13485, EU IVDR, etc.) and Veracyte’s quality standards
• Collaborate with internal stakeholders such as R&D and Supply Chain to define supplier selection criteria and ensure new suppliers are qualified according to established procedures
• Conduct suppliers and CMOs quality audits and ensure timely closure of audit findings
• Develop, implement, and maintain supplier quality metrics and monitoring programs
• Lead or support investigations of supplier and CMO related quality incidents, perform root cause analysis, assess impact on product or regulatory compliance
• Develop and maintain Approved Supplier Lists (ASL) and associated documentation
• 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 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
• Collaborate cross-functionally to manage technical transfers, validations, and new product introductions at CMOs
• Support internal and external audits (e.g., FDA, Notified Body) related to supplier quality and provide necessary documentation and evidence
• Drive continuous improvement of supplier management processes and standards

 

 

 

Who You Are:

Qualifications

 

• Bachelor’s degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field
• 5+ years hands‑on quality assurance experience in the medical device or in‑vitro diagnostic (IVD) industry
• In‑depth knowledge of in‑vitro diagnostic device quality requirements, including ISO 13485:2016, IVDR (EU 2017/746) and, ISO 14971:2019 risk management
• Strong background in supplier quality management and oversight of CMOs
• Proven experience conducting supplier audits and managing supplier corrective actions
• 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 eq