Senior Quality Technician

The Senior Quality Technician is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. The Senior Quality Technician supports manufacturing and servicing operations by coordinating problem-solving investigations and in-process and final QC product acceptance testing. Senior Quality Technicians open and lead investigations of product and process non conformances and assist in the implementation of improvements. This role also leads device history record review and coordinates the execution of calibration and environmental monitoring processes. In addition, Senior Quality Technicians track, trend and analyze quality data.

1. May coordinate & conduct in-process and final QC product acceptance testing.
2. Coordinates production line Quality investigations and problem-solving activities.
3. Identifies and documents product and process non-conformance investigations.
4. Opens and leads investigations of product and process non conformances.
5. Coordinates Material Review Board to review and process non conformance reports.
6. Leads DHR's and batch record reviews to ensure compiance to regulations and standards.
7. Analyzes and trends Quality data from local and global systems.
8. Coordinates site calibration activities and recordkeeping.
9. Coordinates environmental monitoring processes and recordkeeping.
10. Make suggestions and support implementation of manufacturing and quality improvements.
11. In Sterilization facilities, execute tests associated with dosimeter reading equipment, dosimeter calibrations and dosimeter batch acceptance.
12. Complete other duties as assigned.

• Minimum of five (5) years of experience in a manufacturing or repair environment or other technical production tasks with a high school diploma or equivalent.
• Minimum of three (3) years of experience in a manufacturing or repair environment or other technical production tasks with an Associate Degree.