Quality Engineer (Validation Project)
The purpose of the position is to provide Quality Engineering and Process Validation services for Continence products in the CCBM Plant.
- Complete Process and Equipment Validation including DV, IQ, OQ, PQ protocol development, implementation and report completion.
- Develop product specifications / drawings / quality plans in conjunction with NPD and project team.
- Conduct Risk Management / FMEA / Statistical analysis.
- Complete ISO 13485 / FDA and QSR internal audits per annual schedule.
- Implement process control and ensure process capability is maintained and identify opportunities for process improvement.
- Conduct CAPA analysis to determine root cause and complete problem resolution.
- Personnel training.
- Degree in Engineering/Science Discipline
- Quality Engineering Qualification
- Experience in statistical analysis / process validation
- 2/3 years experience in Medical Device Industry
- Ability to participate in cross functional teams