QAQE for Products and Systems
Core
Guides implementation of comprehensive process validation plans and ensures smooth transition of new medical products to production while managing design control and regulatory compliance.
Role type
Senior Quality Assurance Engineer (Medical Devices)
Builds
Medical device products and systems
Domain
Medtech / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation, Design control, Root cause analysis, Risk management, Regulatory compliance, Quality audits, Post-market surveillance, CAPA methodologies, Design verification, Statistical tools
Preferred skills
Data analysis, Technical documentation, Continuous improvement, Defect management, Design for Quality
Technologies
None stated
Responsibilities
Guide implementation of process validation plans, ensure execution of design control process, review quality engineering documents, propose quality improvement projects, evaluate product designs and perform root cause analysis, validate essential design inputs, support quality audits and inspections
Seniority
Senior, hands-on IC