Sr. Quality Engineer
Core
Guides process validation and design control to ensure new medical device products transition effectively to production while maintaining regulatory compliance.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Validated medical device products compliant with ISO 13485 and regulatory standards
Domain
Healthcare / Medical Devices / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process Validation, Design Control, Root Cause Analysis, Regulatory Compliance, Risk Management, CAPA, Statistical Tools, Technical Documentation, Design Verification, Design Validation
Preferred skills
Six Sigma Green Belt, ISO 13485, ISO 14971, Post Market Surveillance, Defect Management, Design for Quality
Technologies
Statistical tools, Post-market analytics
Responsibilities
Guide implementation of process validation plans using statistical tools; Ensure smooth execution of design control processes from inputs to transfer; Review and assess quality engineering documents for hardware, software, and system design; Propose and initiate quality improvement projects integrating reliability and PMS plans; Evaluate product designs and perform root cause analysis for quality deficiencies; Validate essential design inputs including usability, reliability, and safety; Support quality audits and inspections; Apply continuous improvement techniques to enhance quality practices.
Seniority
Senior, hands-on IC