Performs inspection and testing of medical devices. Reviews documentation to ensure completeness and accuracy. Coordinates calibration of measuring equipment.
• Performs quality control functional testing of assembled medical device documenting quality data, and approving final product quality of manufactured devices.
• Oversees calibration program to include documentation, performing calibrations, and working with vendors for outside calibration services.
• Assists Material Review Board in documenting and resolving non-conforming product.
• Performs component and device failure investigations.
• Assists personnel as needed in documentation, assembly, disinfection, and packaging areas.
• Assists in Corrective and Preventive Action programs.
• Assists in Engineering Change Order process.
• Assists in Training.
• Assists in Internal Quality Audits.
• Associates degree in a technical field.
• Five years experience in medical device industry.
• Knowledge of ISO 13485 and 21 CFR 820
• Ability to communicate effectively both verbally and in writing.
• Ability to use various hand tools and work with small components.