POSITION SUMMARY:
The QA/RA Engineer will support the integrity of the Quality Management System and provide required regulatory support as required for new product enhancements or regulatory changes. The position reports into the Director QA/RA.
ESSENTIAL FUNCTIONS:
- Provides regulatory support to IZI locations.
- Serves as back up for Quality Engineer and Quality Supervisor.
- Manages and supports software training platform for all GMP/ECO related engineering and production changes.
- Works closely with QA/RA Director to support new licenses/approvals for new products or countries.
- Provides RA support consistent with all changing regulatory requirements.
- Has overall responsibility for the Company QMS program and adherence including risk analysis, deviations, NCMR’s, etc.
MINIMUM QUALIFICATIONS:
- Bachelor’s degree in Engineering plus the desire to start a QA engineering career in Medical Devices.