quality 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

Job Requirements

• 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