Quality Engineer II
Core
Leads quality engineering activities including risk assessments, test methods, component qualifications, and design validation for medical device product lines.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Medical device products compliant with industry standards and regulatory requirements
Domain
Medical Technology / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management (ISO 14971), Quality Engineering tools (Root Cause Analysis, Statistics), Design validation, Process validation, Component qualification, Regulatory compliance (ISO 13485), Supplier audit coordination, Cross-functional team leadership
Preferred skills
ASQ Quality Engineering Certification, Electrical Engineering background
Technologies
ISO 13485, ISO 14971, Statistical analysis tools
Responsibilities
Lead development of risk assessments and test methods; Lead component qualifications and design validation; Coordinate product development activities; Support internal and external supplier audits; Prepare technical submissions for regulatory departments; Analyze and optimize manufacturing and quality systems
Seniority
Mid-Senior, hands-on IC with leadership responsibilities
