Veracyte, Inc. · 5 hours ago
Quality Manager, Supplier QA
San Francisco Bay Area
Contract
Hybrid
Mid, Senior Level
$129K/yr - $142K/yr
6+ years expVeracyte, Inc. is a global diagnostics company committed to transforming cancer care for patients worldwide. They are seeking a Quality Manager, Supplier QA to lead the qualification and oversight of contract manufacturers and suppliers, ensuring compliance with regulatory requirements and internal quality standards.
BiotechnologyHealth CareHealth Diagnostics
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
Qualification
Required
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
Preferred
ISO 13485 Lead Auditor or equivalent lead auditor certificate
Benefits
Competitive compensation and benefits
Additional discretionary bonuses/incentives
Restricted stock units
Company
Veracyte, Inc.
Veracyte is a global diagnostics company that empowers clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer.
501-1000 employees
H1B Sponsorship
Veracyte, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (17)
2023 (7)
2022 (2)
2021 (6)
2020 (8)
Funding
Current Stage
Public CompanyTotal Funding
$1.1BKey Investors
Visium Healthcare PartnersGE VenturesDomain Associates
2021-02-05Post Ipo Equity· $550M
2020-08-05Post Ipo Equity· $194M
2019-05-01Post Ipo Equity· $137.8M
Leadership Team
John Leite
Chief Commercial Officer (CCO)
Recent News
2026-01-12
TradingView
2026-01-12
Company data provided by crunchbase