Description
Principal Duties & Responsibilities- Formulates procedures, specifications, and standards for
- Provides leadership for quality engineering projects from concept through design, implementation, testing, documentation, support, and maintenance.
- Develops and implements corrective/preventative action plans.
- Collects and analyzes data for gauge and product evaluation.
- Develop and maintain an effective and robust quality system which complies with all relevant regulatory requirements.
- Ensure all validation activity is effective and documented in a compliant manner.
- Complete in-depth investigations into customer complaints and implement corrective and preventative actions, as appropriate.
- Identifies critical personnel, gauges, procedures, and materials needed for the completion of new products.
Requirements
- Third Level Degree in Quality or Engineering field
- Previous Medical Devices experience - particularly in Validations
- Understanding of QSR/ISO regulations
- Risk assessment skills using FMEA methodology
- Knowledge of statistics, process control, and process capability.