SynthBee
Director of Quality
HQ +1 · Director · Full-time · Posted Sep 14, 2026
- Location
- HQ
Pembroke Pines, Florida, United States - Experience
- 10+ years of progressive quality experience in highly regulated technical fields, including at least 3–5 years in a leadership/management capacity.
- Education
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field; Master’s/MBA preferred.
About the job
Own SynthBee’s quality strategy and build a scalable Quality Management System (QMS), quality culture, and team for regulated, multi-industry operations.
What you'll do
- Define corporate quality strategy and compliance roadmaps; oversee QMS implementation and continuous improvement.
- Lead audits, regulatory submissions, CAPA, and enterprise risk management while maintaining inspection readiness.
- Build the Quality team and partner with Software, IT, and AI Engineering to apply quality standards across systems.
What they ask for
- Mastery designing, scaling, and managing QMS infrastructures aligned with ISO 9001.
- Deep experience bridging software, including AI/ML frameworks, and hardware engineering lifecycles.
- Expertise integrating Agile and DevOps practices into regulated environments.
- Proven experience with regulatory bodies and high-stakes external audits.
Nice to have
- Knowledge, oversight, or certification in one or more listed standards, including ISO 13485, FDA 21 CFR Part 820 (QSR), SaMD, or IATF 16949.
- Experience with Design Controls and quality across R&D through post-market surveillance; ASQ certifications or equivalent credentials are highly desirable.
Tools
ISO 9001, AI/ML, Agile, DevOps, ISO 13485, FDA 21 CFR Part 820 (QSR), SaMD, IATF 16949
AI focus
Partner with AI Engineering and ensure quality standards cover AI/ML frameworks and integrated systems.
Model-written summary · the original posting is authoritative