QC Technician

To ensure all products meet product specifications prior to final acceptance. This includes review and completion of applicable documentation. Additionally, these tasks shall be accomplished in compliance with FDA and ISO Standards as delineated by the Quality Management System. Perform and document inspection requirements following approved SOPs and WIs for incoming and finished products including implants, instrumentation, raw material, and trays.

Document and notify QC Supervisor / Manager of non-conformances (NC). Create NC record, segregate NC product, and completion of NC system tasks as assigned by QC Supervisor/Manager. Assist with Material Review Board process and execute NC dispositions. Perform product inspection in accordance to established Sampling Plans.

Maintain ERP system status and location of product to ensure accurate identification and traceability. Perform Stock Audits as assigned by QC Supervisor / Manager. As needed

• Perform Environmental Monitoring tasks. Perform First Article Inspection (FAI) and/or Special Inspections (SI) per established procedures. Know and apply the Quality System and any appropriate Federal and International standards. Assist and support other employees, teams, and sales personnel as necessary.

Education

High School Diploma or GED required Experience: Prior work in a Quality department in a regulated industry preferred. Experience utilizing Geometric Dimensioning and Tolerancing (GD&T) preferred. Functional/Technical Knowledge, Skills and Abilities Required: Attention to detail, accuracy, and documentation skills. Aptitude to learn the use of basic Quality measurement equipment and tools such as profile overlays, calipers, hand gages, etc.

Basic computer skills Familiar with 21 CFR Part 820 and ISO-13485 subclauses on Acceptance Criteria. Entry level understanding of GD&T ASME Y14.5. Ability to use Micrometers, Calipers, Depth-gauge, Height gauge, Visual Comparator, and Vision-System.