Quality Engineer
Flexible & Integrated Technical Services, LLC
AI assistant
Job Description
For Quality Engineering services in the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor's degree in Engineering, Quality, Biomedical Engineering, or related discipline.
- 5+ years of experience in Quality Engineering within the medical device industry.
- Strong knowledge of Design Controls, Risk Management, Validation, and Regulatory requirements.
- Familiarity with FDA 21 CFR Part 820, ISO 13485, and risk management methodologies.
- Shift: Administrative, and according to business needs.
- Experience in:
- Supporting product transfers, design changes, and process