Engineer II, Manufacturing, Quality Assurance
Core
Lead investigations into manufacturing quality and compliance issues, perform root cause analysis, and drive corrective actions (CAPA) to strengthen quality and regulatory compliance in a medical device manufacturing environment.
Role type
Engineer II, Manufacturing Quality Assurance
Builds
Quality assurance processes, CAPA solutions, and risk management documentation for cardiovascular implant manufacturing
Domain
Medical devices, cardiovascular implants, manufacturing quality
Required skills
root cause analysis, CAPA management, regulatory compliance, risk assessment, process improvement, technical documentation, mentoring
Preferred skills
Lean Six Sigma, statistical analysis (DOE, Control Charting, Hypothesis Testing), medical device industry experience
Technologies
MS Office Suite, MS Project
Responsibilities
lead quality investigations and CAPAs, drive continuous improvement using Lean/Six Sigma, maintain risk management documentation, create manufacturing work instructions, mentor technicians, collaborate with cross-functional teams
Seniority
Mid-level, hands-on IC with mentoring duties
