Quality Technician

The Quality Technician provides support to the Design Quality Engineering (DQE) team in day-to-day activities. The Quality Technician will need to have experience reviewing inspection/test data for Good Documentation Practices and observing testing to ensure compliance with test methods.  The Quality Technician should be competent in performing inspections/testing using various measurement systems and recording data.  

Responsibilities:   

• Review test/ inspection data and ensure data adheres to Data Integrity requirements, including Good Documentation Practices (GDP) 
• Perform basic electronic data entry, calculations, and data analysis. 
• Initiate Document Change Orders to reflect current QMS requirements, for continuous improvement, or update according to GDP requirements: Data collection forms, Procedures, and Test Methods 
• Perform inspection/testing of medical devices components, subassemblies, finished goods, and tools & fixtures using various measurement systems (e.g., visual measurement systems, microscopes, laser micrometer, pin gauges, Instron, calipers, snap/drop gages, balloon burst tester, etc.) and generate NCRs as necessary 
• Perform functional testing of components, assemblies, and or finished products following the required specifications or per test protocols 
• Generate detailed and accurate inspection and testing reports according to Current Good Manufacturing Practices (cGMP) and maintain inspection and testing files as per procedures 
• Handle non-conforming product, including movement to/from quarantine locations and appropriate labeling, and assist in non-conformance investigations 
• Support equipment program by coordinating calibration activities, maintaining equipment status in electronic system, and maintaining qualification records / logs 
• Support company goals and objectives, policies, and procedures, QSR, and FDA regulations 
• Interface and communicate effectively with cross-functional members of project teams 
• Other duties as assigned.  

Requirements: 

• High school diploma with a minimum of 3 years’ experience in the medical device industry (Quality Assurance preferred). Associate’s degree is a plus 
• Understanding of cGMP, QSR and ISO13485 requirements 
• Familiar with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) 
• Ability to understand and follow Quality Management System Procedures (e.g., SOP and Test Methods) 
• Working experience doing data review per Good Documentation Practices (GDP) 
• Working knowledge in reading and interpreting technical specifications and mechanical drawings 
• Experience with data analysis and ability to perform basic calculations 
• Knowledge of a wide variety of inspection, test equipment, and test methodologies 
• Experience performing inspections and testing activities pertaining to Design Validation & Verification in the medical device industry, and recording data following GDP 
• Excellent visual acuity to perform visual inspections involving small defects, small parts, and/or operation of machines using measurement devices 
• Ability to communicate effectively with all cross-functional team members 
• Operate as a team and/or independently while demonstrating flexibility to changing requirements 
• Organized and detail-oriented 
• Proficient with MS Office including Excel and Word 
• May be required to work in a Controlled Environment Room (CER) as needed. 
• Effective written and verbal communication skills 
• Ability to work in a fast-paced environment while managing multiple priorities  
• Experience in a small site environment with developing procedures and variety of responsibilities a plus 
• May be required to lift objects up to 25lbs 

Preferred Experience:  

• Experience with catheter products and their components a plus 
• Experience working in both R&D and production environments and ability to flex between the requirements of each