Description
The Quality Engineer develops, practices, and promotes quality principles throughout the organization to achieve defined customer quality requirements and required regulatory compliance. In addition, this individual provides leadership and guidance to the organization to maintain compliance with QSR and ISO certification.- *CAPA Support
- *Post Market Surveillance
- *Configuration Management
- *Risk Management
- *Process Validation and Test Method Validation
Product Development Engineering Support:
- Create, update and maintain risk management file for sterile disposable product by drafting risk management plan, DFMEA, PFMEA, and risk management report.
- Draft, design and coordinate with approved vendors for Biocompatibility, sterilization and shelf life including reliability studies.
- Support verification and validation activities