Senior Quality Engineer (Hybrid)
Core
Senior Design Quality Engineer responsible for product risk management, design control, post-market surveillance, and quality improvement for neurovascular medical devices.
Role type
Senior IC quality engineer (medical devices)
Builds
Neurovascular medical devices ensuring safety, performance, and regulatory compliance
Domain
Medical device / Healthcare technology
Required skills
structured problem-solving methodologies, quality improvement tools, product testing, validation, verification, risk management, process improvement, statistical analysis, failure investigation, root cause analysis, design review, protocol development, report writing
Preferred skills
medical device industry experience, design controls knowledge, risk management expertise, new product introduction, product lifecycle management
Technologies
risk management software, statistical analysis tools, design control systems
Responsibilities
Develop qualification plans, protocols, and reports; Execute product testing and verification; Perform failure investigations and root cause analyses; Create and maintain risk management documentation; Conduct risk assessments and support design reviews; Analyze test results and process data to recommend quality improvements; Collaborate with engineering, regulatory, and manufacturing teams
Seniority
Senior, hands-on IC