MAIN PURPOSE OF ROLE
This position is responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support.
- Document nonconformances as appropriate and assist in the resolution of nonconformances.
- Initiate related documentation changes request.
- Participation on Nonconformance changes request.
- Perform Process Control & Monitoring of critical-to-quality parameters and specifications.
- Collect data, summarize, analyze, perform basic statistical analysis on, and document test results
- Assist with or perform Gage R&R studies, with the selection, installation and programming of precision measuring equipment and assist in designing, building, and evaluation of test methods, providing improvement recommendations
- Create and maintain control plans for products and processes.
- Assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations.
- Performs other duties as assigned.
- Student of Engineering (at least 30% of degree completion) or Technical Degree (at least 50% of diploma completion). Or minimum 2 years of equivalent experience in medical devices or pharmaceutical quality control.
- Basic use of MS Office software.
- Knowledge of Quality Systems/engineering, required.
- Basic English Level Required.
- Knowledge in blueprint reading and experience with sampling techniques.
- Prior medical device experience.
- Basic knowledge of statistical techniques/ tools.