Staff NPI Quality Engineer
Core
Lead quality assurance, design control, and preventative activities to support the design for manufacture and assembly of new medical devices, ensuring regulatory compliance and process robustness.
Role type
Staff NPI Quality Engineer
Builds
New medical device products and manufacturing processes
Domain
Medical device manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
pFMEA, CQA/CTQ identification, MSA strategy, validation protocols, statistical process control, supplier qualification, PPAP, Design Transfer management, root cause analysis, metrology interpretation
Preferred skills
CQE certification, Advanced Product Quality Planning, Med Device manufacturing experience, ISO 13485/QSR/GMP knowledge, Lean Six Sigma, Computer System Validation
Technologies
pFMEA tools, MSA software, validation protocols, statistical analysis tools
Responsibilities
Lead risk management and pFMEA for production processes; Develop and approve inspection strategies and First Article Inspections; Support validation of processes and sterilization; Manage supplier qualification and PPAP; Represent quality during Design Transfer and audits
Seniority
Staff, technical leadership & mentorship