Chief Quality Architect for Regulated Systems

SynthBee, Inc.; Town of Florida, Northern (NY, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

SynthBee is seeking a Director of Quality to own the strategic vision, architecture, and execution of a scalable QMS across a multi-industry environment. You will drive quality culture within engineering, product, and operations, ensuring alignment with regulatory expectations.

You will partner with executive leadership to mature processes, design multi-year compliance roadmaps, and architect validation frameworks.

Qualifications

• Mastery in designing, scaling, and managing QMS infrastructures aligned with ISO 9001.
• Deep experience bridging software (including AI/ML) and hardware lifecycles.
• Expert at integrating Agile and DevOps in regulated environments; ensure traceability.

Responsibilities

• Define and execute the corporate quality strategy and roadmaps in line with business goals.
• Oversee QMS architecture and continuous improvement across frameworks.
• Recruit, mentor, and develop a world-class Quality team as the company grows.
• Partner with Software, IT, and AI Engineering to embed unified quality standards.
• Lead regulatory audits, submissions, and CAPA strategies; ensure inspection readiness.
• Establish enterprise-wide risk assessment frameworks and root-cause investigations.

Skills

QMS Strategy

Regulatory Expertise

AI/ML Integration

Audit Leadership

Agile Governance

Education

Engineering Degree

ISO Standards

Job description

SynthBee is seeking a Director of Quality to own the strategic vision, architecture, and execution of a scalable QMS across a multi-industry environment. You will drive quality culture within engineering, product, and operations, ensuring alignment with regulatory expectations.

You will partner with executive leadership to mature processes, design multi-year compliance roadmaps, and architect validation frameworks.