Full-Time

Senior Quality Specialist

IVD Quality Team

Posted on 9/9/2025

Veracyte

Veracyte

501-1,000 employees

Genomic cancer diagnostics and non-invasive tests

Compensation Overview

$117k - $130k/yr

+ Bonus + Incentives + Restricted Stock Units

San Bruno, CA, USA

Hybrid

Hybrid role requiring at least 3 days in the office.

Category
Medical, Clinical & Veterinary (1)
Required Skills
Risk Management
Requirements
  • 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
  • Experience implementing and operating a QMS to ISO 13485:2016
  • Experience with design control, risk management (ISO 14971), verification & validation, CAPA, change control, complaint handling, and supplier quality
  • Experience conducting internal audits and supporting external ISO audits or third-party assessments
  • 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
  • Strong writing skills to summarize complex issues clearly and accurately
  • Strong communication, problem-solving, and motivational skills
  • Highly organized, self-motivated, and comfortable working in a fast-paced IVD environment
Responsibilities
  • Support the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and applicable standards and regulations for in vitro diagnostic (IVD) products
  • Drive implementation projects for critical QMS elements (eQMS rollout, CAPA process, supplier qualification program, design control workflows)
  • Develop and update QMS processes and documentation: SOPs, work instructions, templates (DMR/DHF, CAPA, change control, complaint handling, supplier quality, document control, risk management etc.) in accordance with ISO 13485 and IVDR requirements
  • Serve as a Sr. QA subject-matter-expert supporting product development, transfer to CMO, and post market activities for IVDs
  • Support design control and technical documentation: review design inputs/outputs, verification and validation protocols and reports, design history files (DHFs), and IVDR technical documentation
  • Support process and equipment qualifications (IQ/OQ/PQ) and software validation activities as required
  • Manage supplier qualification and ongoing supplier quality monitoring; perform supplier audits and oversee supplier corrective actions
  • Implement and maintain risk management per ISO 14971: facilitate risk assessments, ensure residual risk acceptance, and link risk to design changes and CAPAs
  • Participate in internal audits and support external audits (notified body, regulatory inspections), prepare audit responses, and lead remediation activities
  • Develop, track, and report QMS metrics and KPIs for management review
  • Lead and coordinate CAPA investigations and corrective/preventive actions — ensure root-cause analysis, implementation, and verification of effectiveness within timelines
  • Manage nonconforming product (NCRs), deviations, change control, and product dispositions, ensuring appropriate investigation and documentation
  • Oversee complaint handling: lead investigations, support trend analysis and PMS
  • Other duties as assigned
Desired Qualifications
  • ISO 13485 Lead Auditor or equivalent lead auditor certificate is preferred

Veracyte develops and sells genomic tests used to detect and diagnose cancer. Its tests are non-invasive when possible, using samples such as nasal swabs or tissue biopsies to analyze genetic information and help determine cancer risk or prognosis. One of its notable offerings is the Decipher Prostate genomic classifier, which estimates prostate cancer prognosis, alongside other tests for early lung cancer risk assessment. The company works with hospitals, clinics, and individual practitioners to provide tools that improve diagnostic accuracy and guide treatment decisions. Veracyte differentiates itself by focusing on clinically validated, non-invasive genomic assays that support early detection and personalized care, and by expanding its test portfolio through ongoing research and clinical studies. Its goal is to help healthcare providers achieve earlier, more accurate cancer diagnoses, improve patient outcomes, and use medical resources more efficiently.

Company Size

501-1,000

Company Stage

IPO

Headquarters

San Francisco, California

Founded

2008

Simplify Jobs

Simplify's Take

What believers are saying

  • Q1 2026 revenue grew 21% to $139.1M with net margin expanding from 6% to 21%.
  • Decipher Prostate tests grew 24% to 28K tests; Afirma thyroid grew 12% to 17.2K tests.
  • TrueMRD and Prosigna launches in H1 2026 expand addressable market across bladder and breast cancers.

What critics are saying

  • Oncotype DX Prostate's 12-gene assay captures NCCN-recommended market share from Decipher Prostate.
  • Exosome Diagnostics' urine-based ExoDx test reduces demand for Veracyte's tissue-based prostate analysis.
  • Natera's Signatera MRD assay dominates urologic oncology, threatening TrueMRD bladder cancer launch success.

What makes Veracyte unique

  • Decipher Prostate achieves Level 1B evidence and NCCN guideline inclusion for prostate cancer risk stratification.
  • Decipher GRID database contains 360K transcriptome profiles and 200K digital pathology images for research.
  • Whole-transcriptome sequencing with machine learning across thyroid, prostate, bladder, lung, and breast cancers.

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Benefits

Performance Bonus

Stock Options

Remote Work Options

Growth & Insights and Company News

Headcount

6 month growth

-1%

1 year growth

1%

2 year growth

-1%
Yahoo Finance
Feb 25th, 2026
Veracyte reports Q4 profit of $41.1M, beats analyst expectations with 53 cents per share

Veracyte, a molecular diagnostic company based in South San Francisco, reported fourth-quarter net income of $41.1 million, or 53 cents per share on an adjusted basis, beating Wall Street expectations of 41 cents per share. Revenue reached $140.6 million in the quarter. For the full year, the company posted profit of $66.4 million, or 82 cents per share, on revenue of $517.1 million. Veracyte expects full-year revenue between $570 million and $582 million, indicating continued growth in its diagnostics business.

The Pharma Data
Feb 25th, 2026
Veracyte Advances Urologic Cancer Care With Robust Data at 2026 ASCO GU Symposium

Veracyte advances urologic cancer care with robust data at 2026 ASCO GU Symposium. Veracyte showcases over 15 abstracts highlighting Decipher and TrueMRD genomic tests. What if genomic tests could revolutionize the way The Pharma Data treat urologic cancers? Veracyte, Inc. a leading cancer diagnostics company, is making significant strides in this direction. The company will present more than 15 abstracts at the 2026 ASCO Genitourinary Cancers Symposium (ASCO GU), which takes place from February 26-28 in San Francisco. These studies span prostate and bladder cancers, featuring real-world data for Decipher Prostate and new insights from phase II clinical trials, including one utilizing the company's upcoming TrueMRD(TM) Muscle-Invasive Bladder Cancer (MIBC) test. The breadth of data at ASCO GU shows how its Veracyte Diagnostics Platform is driving meaningful insight across multiple urologic cancers," said Elai Davicioni, Ph.D., Veracyte's medical director, Urology. "In bladder cancer, Decipher is increasingly being integrated into studies that aim to help guide treatment decisions. With TrueMRD, its whole-genome sequencing minimal residual disease platform, The Pharma Data is extending the understanding of tumor evolution and treatment resistance, while also providing critical information to ensure the earlier detection of recurrent disease when a cure may still be achievable. Key insights at a glance. * Decipher Prostate: A 22-gene test that helps inform treatment decisions for patients with prostate cancer. * Decipher Bladder: A 219-gene test that classifies bladder tumors into five molecular subtypes. * TrueMRD: A whole-genome sequencing minimal residual disease platform for tracking cancer recurrence and evolution. * ASCO GU Symposium: Features over 15 abstracts highlighting Veracyte's urology portfolio. The challenge of precision in urologic cancer care. Just as a navigator uses a detailed map to chart a course, Veracyte is using genomic data to guide clinicians in making more precise treatment decisions for urologic cancers. The company's Decipher and TrueMRD tests are designed to provide critical insights into tumor biology and patient outcomes, addressing the significant challenge of tailoring treatments to individual patient needs. This precision is crucial in an era where one-size-fits-all approaches are increasingly recognized as inadequate. The stakes are high, as more accurate and personalized treatments can lead to better patient outcomes and potentially save lives. Why the window for action is closing fast. Like a race against time, the rapid evolution of cancer biology demands immediate and informed action. Veracyte's robust data from the 2026 ASCO GU Symposium underscores the urgency of integrating genomic tests into clinical practice. The SURE-02 phase II trial, for example, highlights the importance of molecular subtyping in muscle-invasive bladder cancer, suggesting a biologically informed strategy for the use of anti-TROP2 ADCs. This approach not only enhances the effectiveness of current treatments but also paves the way for the development of new, more targeted therapies. The conference will provide a platform for clinicians and researchers to share these findings and accelerate the adoption of precision-based care. Veracyte mobilizes genomic insights for clinical decision-making. Veracyte is at the forefront of advancing urologic cancer care through its comprehensive genomic testing platform. The company's Decipher Prostate and Decipher Bladder tests are already making a significant impact, with the Decipher Prostate test achieving "Level 1B" evidence status and inclusion in the most recent NCCN(R) Guidelines for prostate cancer. The upcoming TrueMRD MIBC test, set to be available in the first half of 2026, will further enhance the ability to monitor and manage cancer recurrence. Veracyte continues to strengthen the connection between real-world data and clinical outcomes, ensuring that its tests provide actionable insights for clinicians and patients alike. Future outlook. Veracyte's genomic tests are like a lighthouse guiding ships through treacherous waters, providing clear and reliable information to navigate the complexities of urologic cancer care. The company's commitment to innovation and collaboration is evident in the breadth and depth of the data being presented at the 2026 ASCO GU Symposium. With the upcoming TrueMRD MIBC test and ongoing research, Veracyte is poised to continue driving meaningful advancements in the field. Conclusion. The 2026 ASCO GU Symposium marks a significant milestone for Veracyte and the broader urologic cancer community. By leveraging genomic insights, the company is empowering clinicians to make more informed and precise treatment decisions, ultimately improving patient outcomes. Join the conversation in the comments below. About Decipher Prostate The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients with prostate cancer. The test is performed on biopsy or surgically resected samples and provides an accurate risk of developing metastasis with standard treatment. Armed with this information, physicians can better personalize their patients' care and may recommend less-intensive options for those at lower risk or earlier, more-intensive treatment for those at higher risk of metastasis. The Decipher Prostate test has been validated in many dozens of published studies involving more than 100,000 patients. It is the only gene expression test to achieve "Level 1B" evidence status and inclusion in the risk-stratification table in the most recent NCCN(R) Guidelines* for prostate cancer. About Decipher Bladder The Decipher Bladder Genomic Classifier is a 219-gene test, developed using RNA whole-transcriptome analysis and machine learning, that is designed for use in patients following bladder cancer diagnosis who face questions regarding treatment intensity. The test classifies bladder tumors into five molecular subtypes, each having distinct tumor biology and potential clinical implications. This information can help physicians and their patients better understand the degree of benefit that would likely be gained from neoadjuvant chemotherapy and/or the likelihood of harboring non-organ-confined disease at time of surgery, respectively.

Yahoo Finance
Feb 15th, 2026
UBS reaffirms buy rating on Veracyte after Q4 testing revenue beats expectations at $138-140M

UBS has reaffirmed its Buy rating on Veracyte with a $48 price target following strong fourth-quarter performance. The genomic diagnostics company reported preliminary Q4 2025 revenue of $138-140 million, representing 16%-18% year-over-year growth and exceeding the consensus forecast of $132 million. Analyst Lu Li maintained a positive outlook after Veracyte's Q4 testing revenue surpassed expectations, driven primarily by higher average selling prices and prior-period collections rather than volume growth. The company's 2026 testing revenue projections exceeded street expectations whilst maintaining a projected adjusted EBITDA margin of 25%, up from approximately 21% in 2024. UBS noted potential gains from new product contributions, suggesting current revenue projections don't fully account for all growth prospects. Veracyte develops diagnostic tests for thyroid, lung and other cancers, as well as autoimmune diseases.

360Dx
Jan 15th, 2026
Veracyte Details Upcoming MRD Test, Touts Whole-Transcriptome Sequencing Assay Launches at JPM

Veracyte details upcoming MRD test, touts whole-transcriptome sequencing assay launches at JPM. NEW YORK - Veracyte on Thursday provided some guidance on its plans to launch a minimal residual disease (MRD) test at the JP Morgan Healthcare Conference. Get the full story with 360dx premium.

BioSpace
Sep 25th, 2025
Veracyte Announces First Prospective Validation Data for Biomarker Predicting Hormone Therapy Benefit in Men with Recurrent Prostate Cancer Will Be Presented at ASTRO 2025

Veracyte announces first prospective validation data for Biomarker predicting hormone therapy benefit in men with Recurrent Prostate Cancer will be presented at ASTRO 2025.

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