Job Description
Job Description
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