quality engineer

China·Suzhoumid

EngineeringQuality Engineer

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Overview

Validation Experts Lead investigations for nonconforming material, in-process failures,

Technical Tools

EngineeringQuality Engineer

Validation Experts
Lead investigations for nonconforming material, in-process failures, complaints and field issues
Support new product development / new product introduction to set up validation and process manufacturability
Support product transfers and process and product change notifications (design transfer)
Performs risk assessments in collaboration with cross-functional teams (pFMEAs)
Develop & implement CAPA. Verify & validate CAPA effectiveness
Ensure purchased components meet specifications and quality requirements
Participate in internal audits and support external audits
Support complaint investigations, evaluate returned products & implement feedback loops
Analyze quality data, trends, KPIs to drive CI

~1 min read

5 years’ experience in medical device is desirable
Advance knowledge of investigation of NC, CAPA, complaint
Advance knowledge of data analysis and relative quality statistic method
Advanced knowledge of medical device regulations
Advanced knowledge of medical device validation
Advanced knowledge of applicable quality management and of risk management standards
Knowledge of the design transfer from quality aspect
Knowledge of internal and external processes and structures
Good in stakeholder management and communication
Trusted quality partner in cross-functional project meetings
Fluent in English