Quality Technician - £24,000
Based in Hoddesdon, the 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 Quality Technician supports manufacturing and servicing operations by assisting in performing and documenting problem-solving investigations and conducting in-process sub-assembly and final QC product acceptance testing. Quality Technicians assist in identifying and documenting process and product non-conformances. They work with operations team members to perform and document problem-solving investigations. In addition, Quality Technicians may review device history records, authorize release of finished product/processes and execute calibration and environmental monitoring processes.
1.Assists in production line Quality investigations and associated problem-solving activities.
2.May coordinate and conduct in-process and final QC product acceptance testing, depending on facility.
3.Investigates production line stoppages to identify corrective actions.
4.Identifies and documents product and process non-conformances.
5.Participates on a Material Review Board to review and process non conformance reports.
6.Reviews DHR’s and supports batch record release.
7.Enters and retrieves Quality data from local and global systems.
8.Performs site calibration activities and recordkeeping.
9.Executes environmental monitoring processes and recordkeeping.
10.Verifies calculations, dose ranges, dosimeter placements and special instructions prior to processing and part of final product release.
11.Complete other duties as assigned.