Sr Engineer, Design Quality
Core
Senior Engineer providing quality oversight and risk management for medical device design and development projects.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Safe, effective, and compliant medical devices
Domain
Healthcare / Medical Devices / Quality Engineering
Required skills
Design controls, risk management, root cause analysis, regulatory compliance, statistical methods, technical documentation review
Preferred skills
FMEA, DMAIC, audit support, Six Sigma/Lean certification, FDA inspection experience
Technologies
ISO 13485, ISO 14971, 21 CFR Part 820, IEC 62304, IEC 60601-1, ISO 62366-1
Responsibilities
Provide quality oversight for product design activities (planning, input, output, review, verification, validation, transfer, changes), identify and assess regulatory/quality risks, maintain Design History Files, partner with R&D and Sustaining Engineering on design reviews.
Seniority
Senior, hands-on IC