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 and for assisting quality engineers on the monitoring of quality assurance efforts to ensure that the company’s products conform to quality standards.
- Document nonconformances as appropriate and assist in the resolution of nonconformances.
- Perform inspection of production operations, including documenting inspection and audit results.
- Initiate related documentation changes request. • Perform Process Control & Monitoring of critical-to-quality parameters and specifications
- Develops and documents test plan protocols, test procedures, and test reports, with mentorship from Quality Engineer.
- 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 70% of degree completion) or Technical Degree, or minimum 4 years of equivalent experience in medical devices or pharmaceutical quality control.
- 4+ years’ experience.
- Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
- Knowledge of Quality Systems/engineering required.
- Intermediate command of English required.
- Previous experience in assisting with validations, qualifications, test methods or NCMR.
- Knowledge in blueprint reading and experience with sampling techniques.
- Prior medical device experience.
- ASQ CQT certification or equivalent.
- Basic knowledge of statistical techniques/ tools.