Quality Engineer IV
Core
Leads Workcell Quality Operations or NPI teams to ensure product quality and process compliance in medical device manufacturing.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Quality plans, validation protocols, inspection/testing processes, and corrective actions for medical device products.
Domain
Medical Device Manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality Assurance/Validation)
Required skills
Statistical analysis (Minitab), ISO 13485 compliance, CAPA management, validation planning, root cause analysis, PCBA manufacturing knowledge, team leadership
Preferred skills
ASQ CQE certification, FDA audit experience, PCBA process expertise, mentoring
Technologies
Minitab, Microsoft Office, Quality System software
Responsibilities
Lead quality operations and NPI teams; develop and maintain quality control plans; execute validation activities; analyze quality discrepancies and lead investigations; audit quality systems; manage CAPA implementation; supervise and recruit QA staff.
Seniority
Senior, hands-on IC with team leadership
