Operations QA Lead
Core
Own the Quality Management System (QMS) infrastructure to ensure accuracy, auditability, and continuous improvement of preventive healthcare processes.
Role type
Senior Operations QA Lead (Regulated Industry)
Builds
Quality Management System (QMS) processes, NC/CAPA workflows, supplier oversight mechanisms, and AI-optimized quality tools.
Domain
Healthtech / Medical Device / Pharma (Regulated)
Deliverable
production ML models | dashboards & analysis | client delivery
Required skills
NC and CAPA management, root cause analysis, ISO 13485/EU MDR/IVDR knowledge, supplier quality management, audit support, AI workflow optimization
Preferred skills
Post-market surveillance, training management, supplier audits, eQMS platforms, AI/ML quality tools
Technologies
eQMS platforms, AI/ML-assisted quality tools
Responsibilities
Establish consistent root cause analysis and close outstanding actions for NC and CAPA; introduce trending and early-warning signals across quality data; run training sessions to increase organizational knowledge of quality processes; implement structured supplier evaluation cadences; support internal or Notified Body audit cycles; identify and implement AI-assisted optimizations in quality workflows
Seniority
Senior, hands-on IC
