C

Cytovale

Rapid sepsis diagnostics using host-response technology

Head of Quality and Regulatory

Full-Time
No salary listed
Expert
Bachelor's, Master's, MBA
South San Francisco, CA, USA
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • A bachelor's degree in an engineering discipline.
  • At least 10 years of progressive quality leadership experience in the medical device or IVD industry, including at least 7 years managing quality teams and organizational performance.
  • Demonstrated success leading a Quality Assurance/Regulatory Affairs function at a small- to mid-sized Class II device company, with an emphasis on process and on-market product improvement.
  • Deep working knowledge of FDA QMSR (21 CFR Part 820), ISO 13485, current Good Manufacturing Practices, and IVD-specific regulatory and quality requirements.
  • Experience leading FDA inspections and Notified Body audits and sustaining inspection readiness.
  • Significant experience leading Quality Assurance and Quality Control organizations, including inspection and test method development and validation.
  • Applied expertise in risk analysis, failure mode and effects analysis, impact/hazard analysis, statistical methods, and process and software validation.
  • Ability to lead structured problem solving, apply data- and risk-based decision making, and drive sustainable corrective actions.
  • Experience driving cultural change and building high-functioning cross-functional teams.
  • Thoughtful, analytical, and intellectually curious approach.
Responsibilities
  • Define and execute an enterprise Quality strategy that supports regulatory obligations, operational objectives, and long-term growth; establish annual quality objectives and the key performance indicators used to report progress to executive leadership.
  • Lead a multidisciplinary Quality organization spanning Quality Assurance, Quality Engineering, Design Quality, Quality Systems, Process Validation, Incoming Inspection, and the audit program.
  • Set the strategy for quality infrastructure, including electronic Quality Management System evolution and the application of artificial intelligence and analytics to quality processes.
  • Serve as Management Representative and own the effectiveness of the Quality Management System and its core processes, including corrective and preventive action, nonconformance and deviation management, complaint handling, change control, document control, training, and management review.
  • Drive process improvements that enable the organization to move quickly while maintaining full FDA, ISO, and QMSR compliance, with cohesive, consistent documentation based on continuous-improvement principles.
  • Establish and sustain an operating rhythm for internal audits, annual post-market reviews, and periodic management reviews.
  • Maintain inspection readiness and lead the organization through FDA inspections, Notified Body audits, and third-party registration activities.
  • Direct design quality assurance across product development and design-change programs, allocate resources, manage budgets, and embed quality engineers in project teams to ensure efficient, compliant execution.
  • Partner with the Senior Director of Regulatory Affairs to develop and maintain an 18- to 24-month regulatory roadmap covering letters to file, Special and Traditional 510(k)s, and Predetermined Change Control Plans that enable feature and reliability improvements.
  • Provide subject matter expertise in design of experiments, process validation, statistical methods, software validation, test method validation and measurement systems analysis, risk management and failure mode and effects analysis, and cybersecurity.
  • Own Quality Improvement Plans for the IntelliSep instrument and associated consumables, and partner with Manufacturing and Engineering on qualification, process capability, and design-transfer activities.
  • Govern manufacturing process changes with appropriate validation and documentation, and ensure nonconformances are investigated and closed promptly.
  • Direct the supplier quality program with Supply Chain and Research and Development, including supplier selection and qualification, audits, performance monitoring, and supplier corrective actions.
  • Own the end-to-end post-market surveillance process, from complaint intake through investigation, trending, product-improvement ticketing, and medical device reporting and vigilance reporting.
  • Monitor quality performance through data analysis and trend identification to surface risks early and prioritize improvement initiatives.
  • Lead complex investigations and root-cause analyses, strengthen corrective and preventive action effectiveness, and build organizational capability in structured problem solving.
  • Build, coach, and develop a high-performing team of quality engineers, quality professionals, and future quality leaders; foster accountability, engagement, and ownership at every level.
  • Champion a company-wide culture of quality through hands-on leadership, cross-functional partnership, and visible participation in Quality Engineering and Quality Management System activities.
Desired Qualifications
  • An MBA or master's degree in engineering or a related field.
  • Hands-on experience with electronic Quality Management System platforms and artificial-intelligence-enabled quality tools.
  • Six Sigma Green Belt or Black Belt certification.
  • Certified internal auditor (ISO 13485) or comparable American Society for Quality certification, such as CQA, CQE, or CMQ/OE.

About the company

C

Cytovale

View
Website

Cytovale provides rapid sepsis diagnostics for healthcare providers. It uses the Cytovale system and its flagship IntelliSep test to assess a patient's immune response from a blood sample in under 10 minutes. The system analyzes thousands of cells per second to detect disease signatures, giving clinicians quick, actionable information to diagnose sepsis and guide treatment. Unlike many diagnostics that take hours or days, IntelliSep emphasizes a simple workflow with minimal hands-on time, making it suitable for busy clinical settings. The company differentiates itself through speed, ease of use, and a focus on host-response biology to deliver fast, reliable results for sepsis diagnosis. Cytovale’s goal is to improve patient outcomes and reduce healthcare costs by providing timely diagnostic information that helps clinicians act sooner and more effectively.

Company Size

51-200

Company Stage

Series D

Total Funding

$216.7M

Headquarters

South San Francisco, California

Founded

2013

Get referred to Cytovale

See people who can refer or advise you

Simplify Jobs

Simplify's Take

What believers are saying

  • April 7, 2026, Cytovale hired Eric Khairy to accelerate commercialization.
  • January 12, 2026 recognition and 70,000-plus patients signal expanding market credibility.
  • June 2026 multicenter gains replicated at four hospitals, de-risking broader health-system rollout.

What critics are saying

  • Payer coverage remains fragile; reimbursement depends on 0441U adoption and insurer policy updates.
  • Bayesian Health, Prenosis, and Inflammatix pressure Cytovale from adjacent sepsis-detection angles.
  • If FMOL results fail outside Louisiana, IntelliSep becomes a regional protocol, not a category winner.

What makes Cytovale unique

  • IntelliSep remains the first FDA-cleared emergency-department sepsis diagnostic, using host-response microfluidics.
  • March 23, 2026 data showed 19% lower mortality across four FMOL hospitals.
  • Eight-minute results fit ED triage, and CPT 0441U supports billable workflow.

Help us improve and share your feedback! Did you find this helpful?

Benefits

  • Remote Work Options

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

1%

2 year growth

2%
Yahoo
Aug 4th, 2026
Caristo wins FDA authorization for cardiovascular risk predictor.

Caristo wins FDA authorization for cardiovascular risk predictor. Nick Paul Taylor Tue, August 4, 2026 at 5:00 AM PDT Dive brief: * Caristo Diagnostics has received de novo authorization for an AI tool that quantifies coronary inflammation from routine imaging scans, the company said last week. * The Food and Drug Administration authorization covers a device, CaRi-Heart, that uses coronary computed tomography angiography to estimate a patient's risk of cardiovascular mortality over 10 years. * Research suggests the tool could help physicians stratify risk among patients who present with chest pain but are free from obstructive coronary artery disease. Dive insight: CCTA images the heart and coronary arteries to detect narrowed or blocked vessels. Patients diagnosed with obstructive CAD undergo treatment to clear blockages. People with clear arteries can still suffer heart attacks and other major adverse cardiac events, or MACE. Traditional tools are unable to identify high-risk patients without obstructive CAD. A U.K. study of Caristo's technology found patients without obstructive CAD accounted for two-thirds of MACE and total cardiac deaths. The study enrolled more than 40,000 people undergoing CCTA at eight U.K. hospitals and tracked them for a median of 2.7 years. Technology from Caristo, a University of Oxford spinout, successfully differentiated patients at very high risk of cardiac mortality and MACE from people at low or medium risk. The tool combined a score based on inflammation-induced radiological changes, plaque burden and the patient's risk factors to assign individuals to one of three risk categories. The device is the first technology authorized in the U.S. to quantify coronary inflammation from routine CCTA, Caristo said. The company plans to launch the product commercially in the U.S. this quarter and expand the rollout in the fourth quarter, leveraging reimbursement codes that took effect in January. Caristo has built out its team in preparation for the launch. Stephen Deitsch joined Caristo as CEO in April, bringing experience gained as CFO of OrganOx. Terumo bought OrganOx for $1.5 billion during Deitsch's time as CFO. Last month, Caristo revealed the appointments of David Vort as chief commercial officer and Chris Louk as CFO. Vort previously worked as chief commercial officer at Cytovale and iRhythm Technologies. At Caristo, Vort will oversee commercialization of CaRi-Heart and CaRi-Plaque, which the FDA cleared last year for coronary plaque and stenosis quantification. Recommended Reading

PR Newswire
Apr 7th, 2026
Cytovale hires Eric Khairy as CMO to accelerate 8-minute sepsis test adoption

Cytovale, a medical diagnostics company focused on early sepsis detection, has appointed Eric Khairy as Chief Marketing Officer. Khairy will lead global marketing strategy as the company scales adoption of IntelliSep, its rapid sepsis test that delivers results in eight minutes. Khairy joins from Inari Medical, where he served as Senior Vice President of Marketing and Commercial Operations, helping grow the company from $6 million to $600 million in annual revenue over seven years through its $1 billion IPO and subsequent $4.9 billion acquisition by Stryker. He previously held leadership roles at Philips, Volcano and other medical technology firms. IntelliSep is FDA-cleared and has reached over 65,000 patients. The test uses artificial intelligence and microfluidics to assess immune system response to infection.

Carpenter Media Group
Apr 7th, 2026
Cytovale appoints Eric Khairy as Chief Marketing Officer.

Cytovale appoints Eric Khairy as Chief Marketing Officer. PR Newswire Today at 6:15am PDT Veteran MedTech commercial leader brings over two decades of operating experience to drive program-building enabled by company's rapid sepsis test SAN FRANCISCO, April 7, 2026 /PRNewswire/ - Cytovale(R), a commercial-stage medical diagnostics company focused on the early detection of sepsis, today announced the appointment of Eric Khairy as Chief Marketing Officer. In this newly created role, Khairy will lead global marketing strategy and execution as the company accelerates adoption of its IntelliSep(R) rapid sepsis test. "Eric brings deep commercial experience from high-growth top-tier MedTech organizations," said Cytovale CEO Ajay Shah. "He has successfully built and scaled teams that support product adoption and growth, and he understands how to translate clinical innovation into broad patient impact. His expertise strengthens our executive leadership team as we bring IntelliSep to more emergency departments across the nation." Khairy joins Cytovale from Inari Medical where he served as Senior Vice President of Marketing and Commercial Operations, helping to fuel the company's growth from $6 million to $600 million in annual revenue over his seven-year tenure, from startup through a $1 billion IPO and subsequent $4.9 billion acquisition by Stryker. Prior to Inari, Khairy held commercial and strategy leadership roles at Philips, Volcano, Corindus Vascular Robotics, and Minogue Medical. "Sepsis is a leading cause of in-hospital death and the most expensive condition to treat, and every hour of delayed treatment costs lives. We can do better," Khairy said. "Cytovale's IntelliSep delivers an actionable sepsis test result in 8 minutes, not days. This solution has already reached over 65,000 patients, and I'm excited to accelerate its adoption." Khairy holds an MBA from MIT, an M.A.Sc. in biomedical engineering from the University of Montreal, and a B.Eng. in computer engineering from McGill University. About IntelliSep(R) IntelliSep is Cytovale's U.S. Food and Drug Administration-cleared rapid sepsis diagnostic, which leverages artificial intelligence (AI) and advanced microfluidics to provide Emergency Department clinicians with an objective and highly sensitive early detection tool for sepsis. IntelliSep assesses the body's dysregulated immune system response to infection and provides a risk score for sepsis within approximately eight minutes using a standard blood draw. For more information, visit cytovale.com/our-solution/intellisep-sepsis-test/. About Cytovale(R) Cytovale is committed to improving patient care by pioneering early detection technologies that assess immune activation to accelerate the time it takes to get from triage to life-saving therapies. Cytovale developed IntelliSep(R), the U.S. Food and Drug Administration-cleared rapid sepsis diagnostic for use with a standard blood draw in Emergency Departments to determine risk of sepsis. Cytovale is based in San Francisco and venture-backed by Norwest Venture Partners, Sands Capital and Global Health Investment Corporation (GHIC). For more information, visit cytovale.com and follow Cytovale on LinkedIn. SOURCE Cytovale This is a paid placement. For further inquiries, please contact PR Newswire directly.

PR Newswire
Jun 12th, 2025
Cytovale'S Rapid Diagnostic Slashes Sepsis Mortality By 39%, Peer-Reviewed Study Confirms

Cytovale's IntelliSep ® sepsis test highlights a new model for ED triage that's already delivering systemwide clinical and economic valueResults of real-world study with 12,000+ patients published in the journal HealthcareSAN FRANCISCO, June 12, 2025 /PRNewswire/ -- One of the largest real-world studies of a sepsis diagnostic reveals that Cytovale's IntelliSep®, a U.S. Food and Drug Administration (FDA)-cleared rapid host response diagnostic, reduced the relative rate of sepsis mortality by 39%, shortened length of hospital stay and enabled more efficient resource allocation in the emergency department (ED). The study, " Impact of a Sepsis Quality Improvement Initiative on Clinical and Operational Outcomes ," published in the peer-reviewed journal Healthcare, followed more than 12,000 patients over 12 months at Our Lady of the Lake Regional Medical Center (OLOLRMC), a 900-bed in-patient acute care facility and Level 1 trauma center in Baton Rouge, La."This is the kind of data the medical field has been waiting for and the results represent a breakthrough in sepsis care," said Dr. Christopher Thomas, study author who serves as Vice President and Chief Quality Officer at Franciscan Missionaries of Our Lady Health System (FMOLHS) and is a critical care physician at Louisiana State University Health Sciences Center. "With this small operational change, we are able to save more lives, deliver better care faster and optimize use of hospital resources. It's a pivotal step forward in how emergency departments manage sepsis

PR Newswire
Mar 21st, 2025
Cytovale Names Rhonda Collins Chief Nursing Officer

Seasoned nurse executive and health IT leader to drive expansion of nurse-driven sepsis protocol leveraging IntelliSep® rapid detection solutionSAN FRANCISCO, March 18, 2025 /PRNewswire/ -- Cytovale® , a commercial-stage medical diagnostics company, today announced the appointment of Rhonda Collins, DNP, RN, FAAN, as the company's first chief nursing officer (CNO). A former nurse, seasoned hospital executive and leader in healthcare IT, Collins will oversee Cytovale's clinical consultant team as they engage with hospital executives around the country to implement nurse-driven sepsis protocols with the company's rapid sepsis detection solution, IntelliSep® ."We've seen strong clinical improvements – including a 30% reduction in risk-adjusted mortality – when hospitals use IntelliSep as part of a nurse-driven sepsis protocol in their emergency departments. We're now looking to bring that same protocol to hospitals across the U.S.," said Ajay Shah, Cytovale co-founder and CEO. "Rhonda, with her deep understanding of nursing workflows and implementing new technologies, will be instrumental in helping more hospitals develop effective sepsis protocols that empower the nursing staff and benefit their patients."A registered nurse for over three decades, Dr. Collins was a hospital executive before continuing her evolution to become a leader in healthcare IT. She comes to Cytovale from Kontakt.io, where she served as CNO