Senior Quality Engineer
Core
Provide quality engineering support and direction in quality assurance, control, and preventative activities within operations to ensure product and process compliance and continuous improvement.
Role type
Senior Quality Engineer (Manufacturing/Operations)
Builds
Manufacturing processes for existing and new products
Domain
Medical Device Manufacturing / Regulated Environment
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, Risk management, Statistical methods, Process validation, Change management, Audit interface, Human Factor analysis, KPI monitoring, Inspection methods optimization
Preferred skills
Lean Six Sigma, ISO 13485/GDP/GMP knowledge, Med Device manufacturing experience, CQE certification
Technologies
Microsoft Word, Microsoft Excel, PowerPoint
Responsibilities
Lead and participate in the development and improvement of manufacturing processes; Oversight and approval of NC & CAPA; Analysis and review of concession requests; Review and approval of change management activities; Maintain KPI for monitoring of process quality; Support execution and analysis of QATs; Assist in the development, review & approval of process and equipment validation/qualification; Coach and mentor others in quality topics.
Seniority
Senior, hands-on IC