About this role
- 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.