Senior Quality Engineer - Design Assurance
Core
Lead design control and risk management activities to ensure medical device compliance and bring new products to market.
Role type
Senior Quality Engineer (Design Assurance)
Builds
Medical devices for breast cancer diagnostics and treatment
Domain
Life sciences / Medical device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control principles, Risk management (ISO 14971), Process validation, Manufacturing qualifications, Regulatory standards (21 CFR 820, ISO 13485), Quality Management Systems (QMS)
Preferred skills
Leading external audits, Non-product software validation, Six Sigma, Certified Quality Engineer
Technologies
ISO 14971, 21 CFR 820, ISO 13485
Responsibilities
Lead design quality for NPD projects, Maintain risk management files, Provide technical support for audits, Author quality procedure updates, Train employees on QMS elements
Seniority
Senior, hands-on IC