Elkhart, United States
2 months ago
The Quality Engineer will assist in the maintenance and support of the Quality Management System activities at an in-vitro diagnostic manufacturing site.
This position is an individual contributor role and will interact with multiple functions within the site.
- Manage calibration and maintenance system.
- Coordinate internal and 3rd party calibration activities.
- Document, review, and file quality records.
- Manage the electronic calibration and maintenance system including enrollment, change, and asset tracking.
- Assist Quality Group in support of related processes and documentation.
- Strong value orientation with the ability to lead teams and positively influence outcomes.
- Ability to effectively communicate with internal and external customers.
- Ability to demonstrate lean leadership skills.
Required Knowledge/Skills, Education, Experience
- BS in Life Science - Biochemistry, Biology, or Chemistry disciplines preferred.
- Requires technical knowledge in IMTE calibration and related electronic management systems.
- Require technical knowledge in the applicability of 21 CFR 820 regulations and ISO 13485:2016 standard requirements.
Preferred Knowledge/Skills, Education, Experience
- IMTE Calibration Management Experience.
- Regulated Industry Experience.