Quality Management System Engineer
Core
Design, develop, and implement quality management systems aligned with industry standards (ISO 9001, ISO 13485, AS9100) to ensure organizational compliance and drive continuous improvement.
Role type
Quality Management System Engineer
Builds
Comprehensive quality management systems, policies, procedures, and process maps
Domain
Manufacturing / Quality Assurance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, Corrective and Preventive Action (CAPA), Audit procedures, Process improvement methodologies (Lean, Six Sigma, Kaizen), Data analysis, Failure Mode and Effects Analysis (FMEA), Risk management, Technical writing, Project management
Preferred skills
ASQ CQE or CQA certification, ISO 9001:2015 Lead Auditor certification, Experience in regulated industries (aerospace, automotive, medical devices, pharmaceuticals)
Technologies
ERP systems, MES systems
Responsibilities
Conduct internal and external audits to assess compliance, Analyze quality data and metrics to identify trends and root causes, Develop and execute CAPA plans, Create and maintain quality documentation, Perform FMEA and risk assessments, Provide training and guidance on quality procedures, Monitor and report on quality KPIs
Seniority
Mid-level (3+ years experience)