Quality Engineer II
Core
Support product development, design change, validation, and quality system activities to ensure regulatory compliance and product quality for medical devices.
Role type
Mid-level IC Quality Engineer (Medical Devices)
Builds
Medical device products and manufacturing processes
Domain
Medical Technology / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Controls, validation principles, risk management, FDA regulations, quality systems documentation, FMEA/FMECA/FTA, process validation, technical writing
Preferred skills
Product development program support, Design History Files (DHF) management, Engineering Change Requests (ECR), internal/supplier audits, medical device industry experience
Technologies
None explicitly stated
Responsibilities
Serve as Quality representative on cross-functional project teams; Create and maintain Design History Files (DHF) and quality system documentation; Develop validation protocols (Process, Product, Stability) and reports; Conduct risk assessments (FMEA, FMECA, FTA); Participate in internal and supplier quality audits; Support continuous improvement initiatives
Seniority
Mid-level, hands-on IC
