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.