DESCRIPTION

To ensure all products meet Exactech 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.

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.

• 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.
• 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.
• 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.