About this role
- 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