Engineer II, QA - Miami, FL
Core
Ensure compliance with quality standards and regulatory requirements across manufacturing operations, leading investigations and implementing corrective actions.
Role type
Quality Engineer II (GMP/ISO regulated environments)
Builds
Quality oversight for critical products in medical devices, pharmaceuticals, or biotechnology
Domain
Life Sciences / Manufacturing Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
statistical analysis, root cause analysis, CAPA, change control, risk management, internal audits, regulatory inspections, quality management software, technical writing, FMEA, complaint resolution
Preferred skills
ISO 13485/FDA Lead Auditor certification, ASQ certification (CQE, CQA), project management
Technologies
TrackWise, SAP QM, Microsoft Office suite
Responsibilities
Perform statistical analysis and support site-level performance KPIs; Plan, develop, and support processes and test plans; Lead investigations and implement corrective actions; Conduct internal audits and support external regulatory inspections; Work directly with customers on complex critical quality issues and complaints; Strategically plan across the network to support AQP establishment; Support the site change control system including process risk assessment using FMEA tools.
Seniority
Mid-level, hands-on IC