Technician Sr Quality

Job description

JOB DESCRIPTION:

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.  

MAIN RESPONSIBILITIES

• 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. 

QUALIFICATIONS 

• 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.  

Preferred Qualifications

• 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. 

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