Job Description
Job Title: Quality TechnicianJob Description
The Quality Technician performs in-process and final inspection of internally produced components and assemblies for an implantable mitral valve system that is currently in an FDA pivotal clinical trial. This role plays a critical part in maintaining the integrity of the Quality Management System (QMS) in accordance with 21 CFR Part 820, ISO 13485:2016, and applicable international standards. The Quality Technician evaluates valve frame subassemblies, sewn textile and biological tissue components, and the associated catheter-based delivery system to ensure each unit meets established acceptance criteria before progressing through manufacturing or being released for clinical use.
Responsibilities
+ Perform dimensional, visual, and functional inspection of nitinol or metal valve frames, sewn tissue leaflets, fabric cuffs, and suture assemblies using calibrated measurement equipment, optical comparators, and microscopy as require...
The Quality Technician performs in-process and final inspection of internally produced components and assemblies for an implantable mitral valve system that is currently in an FDA pivotal clinical trial. This role plays a critical part in maintaining the integrity of the Quality Management System (QMS) in accordance with 21 CFR Part 820, ISO 13485:2016, and applicable international standards. The Quality Technician evaluates valve frame subassemblies, sewn textile and biological tissue components, and the associated catheter-based delivery system to ensure each unit meets established acceptance criteria before progressing through manufacturing or being released for clinical use.
Responsibilities
+ Perform dimensional, visual, and functional inspection of nitinol or metal valve frames, sewn tissue leaflets, fabric cuffs, and suture assemblies using calibrated measurement equipment, optical comparators, and microscopy as require...