Quality Engineer
American Regent(3 months ago)
About this role
The Quality Engineer provides Quality Assurance input for validated systems, preparing and reviewing QA, validation, and QC protocols for complex manufacturing equipment and utilities. The role collaborates with plant quality, manufacturing, calibration services, and R&D to ensure compliance with cGMP and FDA guidance while identifying and resolving key quality issues.
Required Skills
- Validation
- Process Improvement
- cGMP
- FMEA
- DMAIC
- Documentation
- Calibration
- R&D
- Problem Solving
- SOP Development
Qualifications
- BS in Engineering
- BS in Science
- MS Preferred
- 3 Years FDA Experience
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