Job Description
Job Description
Quality Inspector
Contract Role 2+ months
6 am 3 : 30 M-Th and 6-10 Friday with overtime as production requires.
The Quality Inspector 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. Quality Inspectors support manufacturing and servicing operations by performing incoming component and in-process product inspections using standard measurement equipment. They identify, segregate and document rejected material and participate in Material Review Boards to ensure the proper documentation and disposition. They may also review other related Quality documentation such as device history or calibration records.
1. Conducts incoming component and in-process product inspections to appropriate standards.
2. Identifies, segregates and documents rejected components and materials.
3. Participates on a Material Review Board to review and process nonconformance reports.
4. Supports NC disposition activities such as re-inspection.
5. Enters and retrieves inspection and Nc data from local and global systems.
6. Reviews related Quality documentation such as DHR’s or calibration records.
7. Supports local problem-solving activities and may identify opportunities for improvement.
8. Complete other duties as assigned.
REQUIRED : High School Diploma or GED
Describe specific skills and / or business competencies :
Quality Inspector • Mentor, OH, US