Quality Engineer I
Core
Ensures compliance with regulatory requirements and optimizes product development and manufacturing processes for medical devices to impact patient safety.
Role type
Quality Engineer I (Manufacturing & Compliance)
Builds
Optimized manufacturing processes and compliant medical device products
Domain
Medical Devices / Manufacturing Engineering
Required skills
Quality engineering principles, Regulatory compliance, CAPA analysis, Six Sigma, Lean methods, Risk management, Technical documentation, Training development, Equipment testing, Process optimization
Preferred skills
CAD, Statistical techniques, Lab/industrial equipment operation, Power BI, Power Automate, AI knowledge
Technologies
MS Office Suite, CAD, Power BI, Power Automate
Responsibilities
Investigate manufacturing quality and compliance issues; Optimize manufacturing processes using engineering methods; Develop training and documentation materials; Assign support tasks and instruct technicians on conducting tests
Seniority
Mid-level, hands-on IC