Ketryx

SaaS platform for regulated medical software

Director of Quality

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeBoston, MA, USA

About the Job

Requirements

At least 10 years of quality experience at a MedTech, BioPharma, or Life Sciences company.
A track record operating or leading a Quality Management System and supporting external audits in a regulated environment.
Experience owning or materially supporting an Information Security Management System under ISO/IEC 27001 or an equivalent standard.
Strong command of risk-based quality practices and change and release governance.
Ability to communicate clearly with technical and non-technical audiences and strong documentation skills.

Responsibilities

Own the Quality Management System and support the Information Security Management System, keeping policies, standard operating procedures, and records aligned with operations, including ISO/IEC 27001 and SOC 2 programs.
Lead AI governance by owning AI policies and ISO/IEC 42001 conformity, and setting assurance expectations for validated AI agents.
Lead readiness and execution for certifications and audits covering ISO 13485, IEC 62304, ISO 14971, ISO/IEC 27001, SOC 2, IEC 61508, and ISO 26262, as well as customer audits and supplier assessments.
Govern change and release by defining risk-based gates and evidence expectations, and owning release-level risk assessments.
Enable customers and deals by maintaining validation packages and the trust center, and supporting questionnaires, requests for proposals, and strategic accounts where compliance is a blocker.
Monitor emerging regulations, including the EU Medical Device Regulation, EU Cyber Resilience Act, and 21 CFR Part 11, and translate them into internal and customer guidance.
Lead the QA/RA consulting team by staffing engagements, setting deliverable standards, providing final review, and developing consultants.
Partner with Engineering, Product, Security, Sales, and company leadership, and represent Ketryx externally through content, conferences, and standards work.

Desired Qualifications

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 software as a service.
Familiarity with functional safety tool qualification.
Experience leading a team of quality or regulatory professionals.

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 the Company

Ketryx

SaaS platform for regulated medical software

Ketryx offers a Software-as-a-Service Connected Lifecycle Management platform for regulated medical software development. It works by integrating tools for traceability, documentation, Jira, and SBOM management to support planning, development, verification, and maintenance under standards like FDA, IEC 62304, ISO 13485, GMP, and CFR 21 Part 11. The platform targets MedTech teams with an all-in-one lifecycle solution and tiered pricing for startups through large enterprises. Its goal is to reduce compliance risk and development costs while helping customers bring safe, compliant medical software to market faster.

Company size: 51-200
Company stage: Series B
Total funding: $57.1M
Headquarters: Cambridge, MA
Founded: 2021

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