---
title: 'Director of Quality at Ketryx'
canonical: 'https://feeny.ai/job/director-of-quality-ketryx-boston-dnmm79cvyt5r'
type: 'job'
last_seen: '2026-10-26'
---

# Director of Quality at Ketryx

- **Company:** Ketryx
- **Location:** Boston, MA
- **Posted:** 2026-10-22
- **Last confirmed live:** 2026-10-26
- **Apply:** https://job-boards.greenhouse.io/ketryx/jobs/5460839008

## Job description

Job Title: Director of Quality Employment Status: Full-time Office Hours: Monday - Friday; hybrid schedule Location: Boston, Massachusetts Compensation: $150,000 - $185,000, plus equity options. (Compensation dependent on experience level)

The Director of Quality owns Ketryx's Quality Management System (QMS), Information Security Management System (ISMS), AI governance program, and certification portfolio. This leader keeps our processes effective, scalable, and audit-ready while helping the business ship and serve enterprise customers efficiently. Because Ketryx builds compliance software for regulated industries, the role is also an internal reference user of our platform and a public voice on quality and regulatory practice.

## What You'll Do

- Own the QMS and support the ISMS: Keep policies, SOPs, and records aligned with how we operate, including ISO/IEC 27001 and SOC 2 programs.
- Lead AI governance: Own AI policies and ISO/IEC 42001 conformity, and set assurance expectations for validated AI agents.
- Run audits and certifications: Lead readiness and execution for ISO 13485, IEC 62304, ISO 14971, ISO/IEC 27001, SOC 2, IEC 61508, and ISO 26262, plus customer audits and supplier assessments.
- Govern change and release: Define risk-based gates and evidence expectations, and own release-level risk assessments.
- Enable customers and deals: Maintain validation packages and the trust center, and support questionnaires, RFPs, and strategic accounts where compliance is a blocker.
- Track regulation: Monitor emerging requirements (e.g., EU MDR, EU Cyber Resilience Act, 21 CFR Part 11) and translate them into internal and customer guidance.
- Lead the QA/RA consulting team: Staff engagements, set deliverable standards, provide final review, and develop consultants.
- Partner across the company: Work with Engineering, Product, Security, Sales, and leadership, and represent Ketryx externally through content, conferences, and standards work.

How Success Is Measured

- Zero major nonconformities in certification audits, with findings closed on time
- All committed certifications achieved or maintained, including ISO 26262 by August 2027
- Validation packages and risk assessments published for every platform release
- Fast, reliable responses to customer compliance inquiries and deal blockers
- High-quality consulting deliverables with zero quality-related escalations

## What We're Looking For

- 10+ years of experience in quality at a MedTech, BioPharma, or Life Sciences company
- Track record operating or leading a QMS and supporting external audits in a regulated environment
- Experience owning or materially supporting an ISMS under ISO/IEC 27001 or equivalent
- Strong command of risk-based quality practices and change and release governance
- Clear communicator with technical and non-technical audiences, with strong documentation skills

## Nice to Have

- Hands-on audit experience across ISO 13485, IEC 62304, ISO 14971, ISO/IEC 42001, IEC 61508, ISO 26262, and SOC 2
- Experience with AI governance and validating AI-enabled features
- Background supporting customer validation and security questionnaires for enterprise SaaS
- Familiarity with functional safety tool qualification
- Experience leading a team of quality or regulatory professionals

## What We Offer

- Competitive compensation
- Generous stock options possible
- Work in an exciting field with a positive impact on the world
- Opportunity to learn and grow as part of a global team
- Generous PTO for full-time

Ketryx is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances

Ketryx is saving and improving lives by making medical software safe and reliable. We empower software teams building medical applications to create safe, secure, and compliant products used by patients and providers worldwide. We believe that, by automating much of the documentation and quality processes, teams will be able to produce safer and more innovative medical software faster.

Ketryx is at the forefront of helping teams incorporate AI/ML into medical software and that’s why we need you!

## About Ketryx

## Company Overview
- **One-liner**: Ketryx provides an AI-native compliance platform that automates documentation and traceability for regulated software teams, primarily in medical devices and life sciences.
- **Entity Type**: Private (Series B)
- **Headquarters**: Cambridge, Massachusetts, United States
- **Founded**: 2021
- **Founders**: Erez Kaminski (CEO & Founder) and Jan Pöschko (CTO & Founder)

## Core Business
- **Primary industry/industries**: Software Development, Medical Device Compliance, Application Lifecycle Management (ALM), Regulatory Technology (RegTech)
- **Target customers**: B2B, primarily Enterprise teams building safety-critical software in regulated industries (medical devices, life sciences, pharmaceuticals). Customers include four of the top five Fortune 500 MedTech companies.
- **Mission or purpose statement**: "Ketryx helps high-performing teams move at the speed of AI, without compromising on compliance."

## Products & Services
- **Ketryx Platform**: An AI-native compliance platform that overlays existing development tools (Jira, GitHub, etc.) to automate documentation, create real-time traceability, and accelerate release cycles. It includes AI Agents that reduce manual compliance work by up to 90% while keeping humans in the loop for safety-critical decisions.
- **Key Features**: AI-Driven Documentation, Real-Time Traceability, Seamless Integration, Agentic AI, QMS Enforcement, FDA-ready SBOM generation, and auto-generated release notes.

## Market Standing
- **Valuation/Market Cap**: Not publicly disclosed
- **Key Metric**: Total Funding: $57M across rounds (Seed, $14M Series A led by Lightspeed, $39M Series B led by Transformation Capital in September 2025). Annual Revenue: $1.6M (per LinkedIn estimate).
- **Notable Investors/Partners**: Transformation Capital (lead Series B), Lightspeed Venture Partners, E14 Fund (MIT), Ubiquity Ventures, 53 Stations. Former Medtronic CEO Bill Hawkins joined as an investor.
- **Growth Signals**: Headcount grew 92.2% YoY to 122 employees. Products built on Ketryx reach over 100 million patients worldwide. Four of the top five Fortune 500 MedTech companies are customers. The platform accounts for a significant share of FDA AI/ML software approvals.

## Competitive Advantages
- **First-mover in validated AI for regulated industries**: Launched the industry’s first validated AI Agents for regulated environments.
- **Deep regulatory expertise**: Founded by engineers who experienced the pain firsthand, with a team including former FDA regulatory veteran Paul Jones.
- **Seamless integration**: Works as an overlay on existing tools (Jira, GitHub) rather than requiring teams to adopt a new workflow, lowering switching costs.
- **Proven traction**: Trusted by the largest MedTech companies globally, with products impacting hundreds of millions of patients.

## Strategic Focus
- **Global expansion**: Growing teams in Boston and Vienna, with operations in 8 countries.
- **Scaling the platform**: Deepening AI capabilities and expanding integrations to serve the growing demand for validated AI in life sciences.
- **Category creation**: Establishing AI-assisted compliance infrastructure as a competitive necessity for regulated product development.

## Why Work Here
- **Culture**: Described as blending transparency, discipline, and momentum. Values include continuous improvement, taking on ambitious challenges as a team, and prioritizing action over perfection. The company emphasizes a risk-based approach—high standards for patient-impacting work, speed for internal tasks.
- **Remote/Hybrid/Office Policy**: Hybrid model with offices in Cambridge, MA (USA) and Vienna, Austria. Flexible working hours are offered.
- **Notable Perks**: Competitive salary and benefits, parental leave, generous paid holiday calendar, annual company off-site, a culture that values development, and the opportunity to work alongside leaders in the field.
- **Engineering Culture**: Focus on solving tough problems in a fast-growing company. The team includes bright minds in AI, Quality, R&D, and Regulatory Affairs. They value iteration, self-reflection, and experimentation.

## Sources
1. [ketryx.com](https://www.ketryx.com/)
2. [ketryx.com/about/company](https://www.ketryx.com/about/company)
3. [ketryx.com/about/careers](https://www.ketryx.com/about/careers)
4. [linkedin.com/company/ketryx](https://www.linkedin.com/company/ketryx)
5. [ketryx.com/about/open-positions](https://www.ketryx.com/about/open-positions)

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