Open to opportunities

Zachary Sexton

@zacharysexton

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Senior quality leader driving regulated software and medical device compliance.

United States

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What I'm looking for

I seek a senior quality role where I can build and scale QMS for regulated SaaS/medical products, lead cross-functional teams, and drive vendor and regulatory compliance in a collaborative, growth-oriented environment.

I am a senior quality and GxP compliance leader with deep experience building global Quality Management Systems for regulated SaaS and medical device products.

I have led ISO 9001 and ISO 13485-aligned QMS implementations, authored key policies and procedures, and sourced/validated eQMS/eDMS solutions to ensure data integrity and regulatory readiness.

My work spans vendor quality management, design controls, risk-based validation (GAMP 5, IEC 62304), CAPA and audit readiness across FDA, EU MDR, ICH, HIPAA and GDPR frameworks.

I mentor and lead cross-functional teams, drive vendor lifecycle and supplier qualification programs, and provide strategic quality leadership to enable compliant product releases and continuous improvement.

Experience

Work history, roles, and key accomplishments

Current

Director of Quality

Current

OneStudyTeam

Aug 2023 - Present (2 years 7 months)

Developed and implemented an ISO 9001-compliant Global Quality Management System and re-engineered the Software Development Lifecycle, leading design controls and V&V strategy for regulated SaaS products across two organizations.

ISO 9001 Design Control M&V Risk Management

Associate Director of QA

Javara

Jan 2023 - Aug 2023 (7 months)

Developed and implemented a Global QMS and deployed a validated digital QMS/eDMS solution, supporting audit readiness and ensuring clinical trials met GCP/ICH/FDA requirements.

GCP ICH FDA Compliance CAPA

Quality Management Sr. Manager

Health Catalyst

Mar 2021 - Jan 2023 (1 year 10 months)

Authored quality system manuals and deployed eQMS/eDMS tools while building an ISO 13485/21 CFR 820-compliant QMS for SaaS and analytics platforms, and led vendor qualification and CAPA programs.

ISO 13485 21 CFR 820 CAPA Quality

Quality & Supplier Manager

Ancestry

Apr 2017 - Mar 2021 (3 years 11 months)

Led global vendor qualification and supplier quality programs, contributed to FDA 510(k) submission for an IVD device, and implemented eQMS/eDMS to improve supply chain quality across US, EU and APAC.

Supplier Quality ISO 13485 Regulatory Submissions