Veracyte, Inc. · 17 hours ago
Sr. Quality Engineer, Design Control
San Francisco Bay Area
Full-time
Hybrid
Senior Level
$138K/yr - $153K/yr
7+ years expVeracyte, Inc. is a global diagnostics company focused on transforming cancer care for patients worldwide. The Sr. Quality Engineer, Design Control will lead design control activities across the IVD product lifecycle, ensuring compliance with various global regulatory requirements and collaborating with R&D and cross-functional teams to drive effective risk management and audit readiness.
BiotechnologyHealth CareHealth Diagnostics
Responsibilities
Serve as the QA lead on cross-functional product development teams, ensuring design control requirements (FDA 21 CFR 820.30, ISO 13485, IVDR) are incorporated from planning through commercialization
Ensure compliance with all applicable standards, regulations, and internal SOPs throughout the design and development (D&D) process and design changes. Provide guidance on Quality System requirements related to design and development (design history file, design inputs, design outputs, V&V plans and reports, design transfer, device master record etc.) and design changes
Lead risk management activities for projects under design control, ensuring risk management activities comply with internal procedures, ISO 14971, and applicable regulations. This involves issuing the Risk Management Plan and Risk Management Report, leading cross-functional risk management activities including hazard analysis, risk assessments, and ensuring effective risk control measures, residual risk acceptance, and link risk to design changes and CAPAs
Support design verification and validation activities by reviewing protocols and reports to confirm that design outputs meet design input requirements and that analytical and clinical performance is demonstrated. Help resolve any discrepancies through root cause analysis and corrective actions
Ensure ongoing design control compliance for design and post market changes, maintaining DHF integrity throughout product lifecycle
Participate in internal and external audits, serving as the SME for design control and risk management, preparing audit responses, and leading remediation activities
Proactively identify any gaps in compliance and lead CAPA initiatives related to design control or development process issues
Evaluate and implement process improvements to enhance efficiency, compliance, and scalability as Veracyte’s portfolio grows
Develop metrics and KPIs related to design control effectiveness and compliance
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, Biomedical Engineering, Biotechnology, or related technical field
7+ years of experience in Quality Assurance or Quality Engineering in the medical device or IVD industry, with a strong focus on design controls and new product development
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
Hands-on experience with risk management per ISO 14971, design history files, verification & validation, CAPA, and change control
Demonstrated ability to review DHF documentation (design inputs, design outputs, Verification/Validation protocols and reports etc.) for compliance
Comfortable interpreting engineering documentation, specifications, and test data for compliance
Experience managing complex DHF structures digitally
Experience with IVD assay lifecycle (development through commercialization)
Experience with SaMD or algorithm lifecycle management
Strong written and verbal communication skills; demonstrated ability to author clear SOPs, technical documents, and audit responses
Strong problem-solving and organizational skills to manage multiple priorities
Ability to work independently and proactively in a fast-paced environment
Attention to detail in understanding and documenting complex quality issues
Preferred
Relevant certification (e.g., ASQ Certified Quality Engineer, Six Sigma, ISO 13485 Lead Auditor) is a plus
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
2026-01-01
2025-11-11
2025-11-08
Company data provided by crunchbase